Monday, 28 February 2011

Zocor


Zocor is a brand name of simvastatin, approved by the FDA in the following formulation(s):


ZOCOR (simvastatin - tablet; oral)



  • Manufacturer: MERCK

    Approval date: December 23, 1991

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB]


  • Manufacturer: MERCK

    Approval date: July 10, 1998

    Strength(s): 80MG [RLD][AB]

Has a generic version of Zocor been approved?


Yes. The following products are equivalent to Zocor:


simvastatin tablet; oral



  • Manufacturer: ACCORD HLTHCARE

    Approval date: February 26, 2008

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 80MG [AB]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]


  • Manufacturer: BLU CARIBE

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]


  • Manufacturer: DR REDDYS LABS INC

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 80MG [AB]


  • Manufacturer: DR REDDYS LABS INC

    Approval date: January 23, 2008

    Strength(s): 5MG [AB]


  • Manufacturer: IVAX SUB TEVA PHARMS

    Approval date: June 23, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB]


  • Manufacturer: IVAX SUB TEVA PHARMS

    Approval date: December 20, 2006

    Strength(s): 80MG [AB]


  • Manufacturer: LUPIN

    Approval date: May 11, 2007

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 80MG [AB]


  • Manufacturer: LUPIN

    Approval date: April 14, 2009

    Strength(s): 5MG [AB]


  • Manufacturer: MATRIX LABS LTD

    Approval date: June 8, 2010

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]


  • Manufacturer: MICRO LABS LTD

    Approval date: September 16, 2011

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]


  • Manufacturer: RANBAXY

    Approval date: June 23, 2006

    Strength(s): 80MG [AB]


  • Manufacturer: RANBAXY

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB]


  • Manufacturer: WATSON LABS

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]


  • Manufacturer: ZYDUS PHARMS USA

    Approval date: December 20, 2006

    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 5MG [AB], 80MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zocor. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Zocor.

See also...

  • Zocor Consumer Information (Drugs.com)
  • Zocor Consumer Information (Wolters Kluwer)
  • Zocor Consumer Information (Cerner Multum)
  • Zocor Advanced Consumer Information (Micromedex)
  • Simvastatin Consumer Information (Drugs.com)
  • Simvastatin Consumer Information (Wolters Kluwer)
  • Simvastatin Consumer Information (Cerner Multum)
  • Simvastatin Advanced Consumer Information (Micromedex)
  • Simvastatin AHFS DI Monographs (ASHP)

Wednesday, 23 February 2011

Aspirin plus C




Aspirin plus C may be available in the countries listed below.


Ingredient matches for Aspirin plus C



Aspirin

Acetylsalicylic Acid is reported as an ingredient of Aspirin plus C in the following countries:


  • Croatia (Hrvatska)

  • Germany

  • Slovenia

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Aspirin plus C in the following countries:


  • Croatia (Hrvatska)

  • Germany

  • Slovenia

International Drug Name Search

Monday, 21 February 2011

Rokitat




Rokitat may be available in the countries listed below.


Ingredient matches for Rokitat



Roxatidine

Roxatidine acetate hydrochloride (a derivative of Roxatidine) is reported as an ingredient of Rokitat in the following countries:


  • Japan

International Drug Name Search

Sunday, 20 February 2011

Solanax




Solanax may be available in the countries listed below.


Ingredient matches for Solanax



Alprazolam

Alprazolam is reported as an ingredient of Solanax in the following countries:


  • Japan

International Drug Name Search

Friday, 18 February 2011

Lamprene


Lamprene is a brand name of clofazimine, approved by the FDA in the following formulation(s):


LAMPRENE (clofazimine - capsule; oral)



  • Manufacturer: NOVARTIS

    Approval date: December 15, 1986

    Strength(s): 50MG [RLD]

Has a generic version of Lamprene been approved?


No. There is currently no therapeutically equivalent version of Lamprene available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lamprene. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Lamprene.

See also...

  • Lamprene Advanced Consumer Information (Micromedex)
  • Lamprene AHFS DI Monographs (ASHP)
  • Clofazimine Advanced Consumer Information (Micromedex)
  • Clofazimine AHFS DI Monographs (ASHP)

Calcibronat




Calcibronat may be available in the countries listed below.


Ingredient matches for Calcibronat



Calcium Bromolactobionate

Calcium Bromolactobionate is reported as an ingredient of Calcibronat in the following countries:


  • Tunisia

Calcium Bromolactobionate hexahydrate (a derivative of Calcium Bromolactobionate) is reported as an ingredient of Calcibronat in the following countries:


  • Italy

  • Monaco

International Drug Name Search

Tuesday, 15 February 2011

Dactinomycin


Pronunciation: DAK-tin-oh-MYE-sin
Generic Name: Dactinomycin
Brand Name: Cosmegen

Dactinomycin is very toxic. Do not inhale the dust or vapors of Dactinomycin. Do not get Dactinomycin in your eyes, nose, mouth, or onto your skin. Do not come into contact with Dactinomycin if you are pregnant. Dactinomycin is given through a vein. If Dactinomycin leaks out of the vein (extravasation), severe damage to the area around the injection site will occur. Tell your doctor or health care provider immediately if you notice any discomfort, pain, or redness at the injection site.





Dactinomycin is used for:

Treating certain types of cancer. It may be used alone or with other medicines.


Dactinomycin is an antineoplastic. It works by killing certain cancer cells.


Do NOT use Dactinomycin if:


  • you are allergic to any ingredient in Dactinomycin

  • you have chickenpox (varicella infection), or shingles (herpes zoster infection), or if you have had either of these infections recently

Contact your doctor or health care provider right away if any of these apply to you.



Before using Dactinomycin:


Some medical conditions may interact with Dactinomycin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have bone marrow problems or an infection, are scheduled to receive a vaccine, or are very overweight

  • if you are scheduled to have radiation therapy, have had radiation therapy in the last several months, or are receiving any other cancer therapy

Some MEDICINES MAY INTERACT with Dactinomycin. However, no specific interactions with Dactinomycin are known at this time.


Ask your health care provider if Dactinomycin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Dactinomycin:


Use Dactinomycin as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Dactinomycin is usually given as an injection at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions you may have about Dactinomycin.

  • If you get Dactinomycin in your eyes or on your skin, rinse the area with water for 15 minutes. Remove any contaminated clothing and do not reuse. Contaminated shoes must be cleaned completely before reuse.

  • If you miss a dose of Dactinomycin, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Dactinomycin.



Important safety information:


  • If nausea, vomiting, or loss of appetite occurs, ask your doctor about ways to lessen these effects.

  • Dactinomycin may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Dactinomycin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Dactinomycin may increase the risk of developing other cancers (eg, leukemia) when it is used along with radiation therapy. Talk to your doctor if you have questions about your risk of developing other cancers after using Dactinomycin.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Dactinomycin. Talk with your doctor before you receive any vaccine.

  • Lab tests, including liver function, kidney function, and blood counts, may be performed while you use Dactinomycin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Dactinomycin with caution in the ELDERLY; they may be more sensitive to its effects, especially bone marrow problems.

  • Dactinomycin should be used with extreme caution in CHILDREN younger than 6 months old; they are more sensitive to the serious side effects of Dactinomycin.

  • Caution is advised when using Dactinomycin in CHILDREN; they may be more sensitive to its effects, especially severe liver problems.

  • Dactinomycin may slow growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Dactinomycin.

  • PREGNANCY and BREAST-FEEDING: Dactinomycin may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dactinomycin while you are pregnant. It is not known if Dactinomycin is found in breast milk. Do not breast-feed while using Dactinomycin.


Possible side effects of Dactinomycin:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Acne; hair loss; lack of energy; loss of appetite; mild nausea or vomiting; stomach pain; tiredness; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; dark urine; diarrhea; fever, chills, or sore throat; flushing; leg pain or swelling; muscle pain or aches; pale stools; redness, swelling, pain, or blistering near the injection site; severe or persistent nausea or vomiting; shortness of breath; swelling, sores, or ulcers of the mouth or lips; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Dactinomycin side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased amount of urine; mouth pain or swelling; red, swollen, or blistered skin; severe or persistent nausea, vomiting, or diarrhea.


Proper storage of Dactinomycin:

Dactinomycin is usually handled and stored by a health care provider. If you are using Dactinomycin at home, store Dactinomycin as directed by your pharmacist or health care provider.


General information:


  • If you have any questions about Dactinomycin, please talk with your doctor, pharmacist, or other health care provider.

  • Dactinomycin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dactinomycin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dactinomycin resources


  • Dactinomycin Side Effects (in more detail)
  • Dactinomycin Use in Pregnancy & Breastfeeding
  • Dactinomycin Drug Interactions
  • Dactinomycin Support Group
  • 0 Reviews for Dactinomycin - Add your own review/rating


  • Dactinomycin Professional Patient Advice (Wolters Kluwer)

  • Dactinomycin Monograph (AHFS DI)

  • Cosmegen Prescribing Information (FDA)

  • dactinomycin Concise Consumer Information (Cerner Multum)

  • dactinomycin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information



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Saturday, 12 February 2011

Dificid


Dificid is a brand name of fidaxomicin, approved by the FDA in the following formulation(s):


DIFICID (fidaxomicin - tablet; oral)



  • Manufacturer: OPTIMER PHARMS

    Approval date: May 27, 2011

    Strength(s): 200MG [RLD]

Has a generic version of Dificid been approved?


No. There is currently no therapeutically equivalent version of Dificid available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dificid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Polymorphic crystalline forms of tiacumicin B
    Patent 7,378,508
    Issued: May 27, 2008
    Inventor(s): Chiu; Yu-Hung & Che; Tessie Mary & Romero; Alex & Ichikawa; Yoshi & Shue; Youe-Kong
    Assignee(s): Optimer Pharmaceuticals, Inc.
    The invention relates to novel forms of compounds displaying broad spectrum antibiotic activity, especially crystalline polymorphic forms and amorphous forms of such compounds, compositions comprising such crystalline polymorphic forms and amorphous forms of such compounds, processes for manufacture and use thereof. The compounds and compositions of the invention are useful in the pharmaceutical industry, for example, in the treatment or prevention of diseases or disorders associated with the use of antibiotics, chemotherapies, or antiviral therapies, including, but not limited to, colitis, for example, pseudo-membranous colitis; antibiotic associated diarrhea; and infections due to Clostridium difficile (“C. difficile”), Clostridium perfringens (“C. perfringens”), Staphylococcus species, for example, methicillin-resistant Staphylococcus, or Enterococcus including Vancomycin-resistant enterococci.
    Patent expiration dates:

    • July 31, 2027
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
    Patent 7,863,249
    Issued: January 4, 2011
    Inventor(s): Chiu; Yu-Hung & Che; Tessie Mary & Romero; Alex & Ichikawa; Yoshi & Shue; Youe-Kong
    Assignee(s): Optimer Pharmaceuticals, Inc.
    The invention relates to novel forms of compounds displaying broad spectrum antibiotic activity, especially crystalline polymorphic forms and amorphous forms of such compounds, compositions comprising such crystalline polymorphic forms and amorphous forms of such compounds, processes for manufacture and use thereof. The compounds and compositions of the invention are useful in the pharmaceutical industry, for example, in the treatment or prevention of diseases or disorders associated with the use of antibiotics, chemotherapies, or antiviral therapies, including, but not limited to, colitis, for example, pseudo-membranous colitis; antibiotic associated diarrhea; and infections due to Clostridium difficile (“C. difficile”), Clostridium perfringens (“C. perfringens”), Staphylococcus species, for example, methicillin-resistant Staphylococcus, or Enterococcus including Vancomycin-resistant enterococci.
    Patent expiration dates:

    • July 31, 2027
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • 18-membered macrocycles and analogs thereof
    Patent 7,906,489
    Issued: March 15, 2011
    Inventor(s): Shue; Youe-Kong & Hwang; Chan-Kou & Chiu; Yu-Hung & Romero; Alex & Babakhani; Farah & Sears; Pamela & Okumu; Franklin
    Assignee(s): Optimer Pharmaceuticals, Inc.
    The present invention relates generally to the 18-membered macrocyclic antimicrobial agents called Tiacumicins, specifically, OPT-80 (which is composed almost entirely of the R-Tiacumicin B), pharmaceutical compositions comprising OPT-80, and methods using OPT-80. In particular, this compound is a potent drug for the treatment of bacterial infections, specifically C. difficile infections.
    Patent expiration dates:

    • March 4, 2027
      ✓ 
      Patent use: TREATMENT OF MICROBIAL INFECTIONS



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 27, 2016 - NEW CHEMICAL ENTITY

See also...

  • Dificid Consumer Information (Drugs.com)
  • Dificid Consumer Information (Wolters Kluwer)
  • Dificid Consumer Information (Cerner Multum)
  • Dificid Advanced Consumer Information (Micromedex)
  • Fidaxomicin Consumer Information (Wolters Kluwer)
  • Fidaxomicin Consumer Information (Cerner Multum)
  • Fidaxomicin Advanced Consumer Information (Micromedex)

Friday, 11 February 2011

Simcor


Simcor is a brand name of niacin/simvastatin, approved by the FDA in the following formulation(s):


SIMCOR (niacin; simvastatin - tablet, extended release; oral)



  • Manufacturer: ABBOTT

    Approval date: February 15, 2008

    Strength(s): 1GM;20MG [RLD], 500MG;20MG [RLD], 750MG;20MG [RLD]


  • Manufacturer: ABBOTT

    Approval date: July 28, 2010

    Strength(s): 1GM;40MG [RLD], 500MG;40MG [RLD]

Has a generic version of Simcor been approved?


No. There is currently no therapeutically equivalent version of Simcor available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Simcor. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 6,080,428
    Issued: June 27, 2000
    Inventor(s): Bova; David J.
    An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day "nocturnally", that is in the evening or at night.
    Patent expiration dates:

    • May 27, 2017
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • May 27, 2017
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • May 27, 2017
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA




  • Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night
    Patent 6,129,930
    Issued: October 10, 2000
    Inventor(s): Bova; David J.
    An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day "nocturnally," that is in the evening or at night.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA
      ✓ 
      Drug product


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
      ✓ 
      Drug product


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
      ✓ 
      Drug product




  • Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles
    Patent 6,406,715
    Issued: June 18, 2002
    Inventor(s): Eugenio A.; Cefali
    Assignee(s): Kos Pharmaceuticals, Inc.
    Intermediate release nicotinic acid formulations having unique urinary metabolite profiles, which are suitable for oral administration once-a-day as a single dose during a 24 hour period for treating hyperlipidemia without causing drug-induced hepatotoxicity or drug-induced elevations in uric acid or glucose or both to levels that require the therapy to be discontinued, are disclosed.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Drug product




  • Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acid
    Patent 6,469,035
    Issued: October 22, 2002
    Inventor(s): Eugenio A.; Cefali
    The present invention relates to pretreating individuals with an effective amount of a flush inhibiting agent for a sufficient period of time prior to the start of single daily dose nicotinic acid therapy to reduce the capacity of nicotinic acid to induce flushing reactions in such individuals during nicotinic acid therapy. In accordance with the present invention, the flush inhibiting agents are administered orally one to four times a day, and preferably one to two times per day, for between about 7 to about 14 days prior to the start of the nicotinic acid therapy. Examples of flush inhibiting agents include nonsteroidal anti-inflammatory agents. Aspirin is a preferred flush inhibiting agent and may be orally administered in daily doses of between about 80 mg to about 1000 mg, and preferably between about 80 mg and about 650 mg, and more preferably between about 80 mg and about 325 mg, during the pretreatment period. Also consistent with the present invention, the pretreatment therapy may be continued during and administered concurrently with the nicotinic acid therapy, in which the nicotinic acid is preferably administered once per day as a single dose during the evening hours or before or at bedtime. The nicotinic acid may be administered alone or in combination with HMG-CoA reductase inhibitors as well as other lipid-altering agents, like cholestyramine and colestipol.
    Patent expiration dates:

    • March 15, 2018
      ✓ 
      Patent use: TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30 MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN THERAPY


    • March 15, 2018
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN


    • March 15, 2018
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN




  • Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia
    Patent 6,676,967
    Issued: January 13, 2004
    Inventor(s): Eugenio A.; Cefali & David J.; Bova
    Assignee(s): KOS Pharmaceuticals, Inc.
    Methods for reducing flushing in individuals being treated for hyperlipidemia with nicotinic acid are disclosed. According to the methods of the present invention, flushing can be reduced in individuals under going nicotinic acid therapy without causing drug-induced hepatotoxicity to a level that would require the nicotinic acid therapy to be discontinued by orally administering to the individuals intermediate nicotinic acid formualtions having unique biopharmaceutical characteristics as a single dose once per day. While the methods of the present invention contemplate administering the intermediate release nicotinic acid formulations at any time during a 24 hour period, it is preferable to administer them once-a-day as a single dose during the evening or at night between about 6:00 pm. and 12:00 a.m., preferably between about 8:00 p.m. and 12:00 a.m., and most preferably between about 8:00 p.m. and 10:00 p.m.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • September 20, 2013
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT




  • Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
    Patent 6,746,691
    Issued: June 8, 2004
    Inventor(s): Eugenio A.; Cefali
    Assignee(s): Kos Pharmaceuticals, Inc.
    Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, which are suitable for oral administration once per day as a single dose preferably administered during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg. The 375 mg, 500 mg and 750 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F2 of at least 44.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Drug product




  • Intermediate release nicotinic acid compositions for treating hyperlipidemia
    Patent 6,818,229
    Issued: November 16, 2004
    Inventor(s): Eugenio A.; Cefali & David J.; Bova
    Assignee(s): KOS Pharmaceuticals, Inc.
    Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, such as Cmax, Tmax and AUC, which are suitable for oral administration once per day during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Drug product




  • Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 7,011,848
    Issued: March 14, 2006
    Inventor(s): Bova; David J.
    Assignee(s): KOS Pharmaceuticals, Inc.
    An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day “nocturnally,” that is in the evening or at night.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C


    • September 20, 2013
      ✓ 
      Patent use: TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C




  • Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 7,998,506
    Issued: August 16, 2011
    Inventor(s): Bova; David J
    Assignee(s): KOS Life Sciences, Inc.
    An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day “nocturnally,” that is in the evening or at night.
    Patent expiration dates:

    • September 20, 2013
      ✓ 
      Patent use: TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • February 15, 2011 - NEW COMBINATION

See also...

  • Simcor Consumer Information (Drugs.com)
  • Simcor Consumer Information (Wolters Kluwer)
  • Simcor Consumer Information (Cerner Multum)
  • Simcor Advanced Consumer Information (Micromedex)
  • Simvastatin/Niacin Consumer Information (Wolters Kluwer)
  • Niacin and simvastatin Consumer Information (Cerner Multum)
  • Simvastatin and niacin Advanced Consumer Information (Micromedex)

Saturday, 5 February 2011

Genticin




Genticin may be available in the countries listed below.


UK matches:

  • Genticin Eye/Ear Drops (SPC)
  • Genticin Injectable (SPC)

Ingredient matches for Genticin



Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Genticin in the following countries:


  • Ethiopia

  • Ireland

  • United Kingdom

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.