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Generic Gonal-f Availability

See also: Generic Gonal-f RFF, Generic Gonal-f RFF Redi-ject

Gonal-f is a brand name of follicle stimulating hormone, approved by the FDA in the following formulation(s):

GONAL-F (follitropin alfa/beta - injectable;subcutaneous)

  • Manufacturer: EMD SERONO
    Approval date: September 29, 1997
    Strength(s): 75 IU/VIAL, 150 IU/VIAL
  • Manufacturer: EMD SERONO
    Approval date: May 25, 2000
    Strength(s): 37.5 IU/VIAL
  • Manufacturer: EMD SERONO
    Approval date: February 28, 2001
    Strength(s): 1,050 IU/VIAL
  • Manufacturer: EMD SERONO
    Approval date: March 25, 2004
    Strength(s): 37.5 IU/VIAL, 150 IU/VIAL
  • Manufacturer: EMD SERONO
    Approval date: March 26, 2004
    Strength(s): 450 IU/VIAL [RLD]

Has a generic version of Gonal-f been approved?

No. There is currently no therapeutically equivalent version of Gonal-f available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gonal-f. 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.

  • FSH and FSH variant formulations, products and methods
    Patent 7,563,763
    Issued: July 21, 2009
    Inventor(s): Hoffmann; James Arthur & Lu; Jirong
    Assignee(s): Ares Trading S.A.
    This invention relates to FSH or a FSH variant containing an alpha and beta subunit contained in formulations, and articles of manufacture. The invention provides advantageous new proteins and nucleic acids, multi-use pharmaceutical solutions, formulations and products of said proteins and nucleic acids where none approved for commercial use had previously existed having such extended use indications. These products are particularly useful in therapeutic regimens for increasing serum levels of FSH or a FSH variant over a period of treatment. Thus, inter alia, the invention fills the need for convenient products of FSH or from a FSH variant.
    Patent expiration dates:
    • August 23, 2019
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      Drug product

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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