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Generic Fibricor Availability

Fibricor is a brand name of fenofibric acid, approved by the FDA in the following formulation(s):

FIBRICOR (fenofibric acid - tablet;oral)

  • Manufacturer: ATHENA
    Approval date: August 14, 2009
    Strength(s): 35MG (discontinued) [RLD], 105MG [RLD]

Has a generic version of Fibricor been approved?

An Authorized Generic version of Fibricor has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Fenofibric Acid ORAL TABLET 35 mg
    Palmetto Pharmaceuticals, Inc
    NDC Code: 681340601
  • Fenofibric Acid ORAL TABLET 105 mg
    Palmetto Pharmaceuticals, Inc
    NDC Code: 681340602
  • Fenofibric Acid ORAL TABLET 35 mg
    Sarras Health, LLC
    NDC Code: 728340035
  • Fenofibric Acid ORAL TABLET 105 mg
    Sarras Health, LLC
    NDC Code: 728340105

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Fibricor. 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: Generic Drug FAQs.

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.

  • Methods of use of fenofibric acid
    Patent 7,569,612
    Issued: August 4, 2009
    Inventor(s): Arnold; Kristin Anne & Feng; Hengsheng
    Assignee(s): Mutual Pharmaceutical Company, Inc.

    Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.

    Patent expiration dates:

    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
  • Methods of use of fenofibric acid
    Patent 7,741,373
    Issued: June 22, 2010
    Inventor(s): Arnold; Kristin Anne & Feng; Hengsheng
    Assignee(s): Mutual Pharmacuetical Company, Inc.

    Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.

    Patent expiration dates:

    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
  • Methods of use of fenofibric acid
    Patent 7,741,374
    Issued: June 22, 2010
    Inventor(s): Arnold; Kristin Anne & Feng; Hengsheng
    Assignee(s): Mutual Pharmaceutical Company, Inc.

    Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.

    Patent expiration dates:

    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS
  • Methods of use of fenofibric acid
    Patent 7,915,247
    Issued: March 29, 2011
    Inventor(s): Arnold; Kristin Anne & Feng; Hengsheng
    Assignee(s): Mutual Pharmaceutical Company, Inc.

    Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.

    Patent expiration dates:

    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
    • August 20, 2027
      ✓ 
      Patent use: ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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