Generic Finacea Availability

Finacea is a brand name of azelaic acid topical, approved by the FDA in the following formulation(s):

FINACEA (azelaic acid - gel;topical)

  • Manufacturer: BAYER HLTHCARE
    Approval date: December 24, 2002
    Strength(s): 15% [RLD]

Has a generic version of Finacea been approved?

No. There is currently no therapeutically equivalent version of Finacea available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Finacea. 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.

  • Composition with azelaic acid
    Patent 6,534,070
    Issued: March 18, 2003
    Inventor(s): Patrick; Franke & Clemens; Günther & Jutta; Riedl
    Assignee(s): Schering Aktiengesellschaft
    The invention relates to a pharmaceutical composition having the following constituents: azelaic acid, polyacrylic acid, triacylglyceride, propylene glycol, polysorbate, soya lecithin, water and salts. The composition is a hydrogel which is suited for the treatment of rosacea, presbyderma, melasma or skin irritations.
    Patent expiration dates:
    • November 18, 2018

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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