Generic Gonal-f RFF Availability

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

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

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

  • Manufacturer: EMD SERONO
    Approval date: March 25, 2004
    Strength(s): 75 IU/VIAL [RLD]

Has a generic version of Gonal-f RFF been approved?

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

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

  • Follicle stimulating hormone and pharmaceutical compositions containing same
    Patent 5,767,067
    Issued: June 16, 1998
    Inventor(s): Arpaia; Guiseppe & Serani; Serenella & Sirna; Antonino & Villa; Stefano
    Assignee(s): Istituto di Ricerca Cesare Serono S.p.A.
    Purification of human FSH from post-menopausal urine gonadogropin using immunochromatography and reverse phase HPLC steps yelds a biologically active hormone which is free from detectable traces of LH and other urinary proteins.
    Patent expiration dates:
    • June 16, 2015
      ✓ 
      Drug substance
  • Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof
    Patent 5,767,251
    Issued: June 16, 1998
    Inventor(s): Reddy; Vermuri B. & Hsiung; Nancy & Beck; Anton K. & Bernstine; Edward George
    Assignee(s): Genzyme Corporation
    Biologically active heterodimeric human fertility hormones composed of two different subunits, each subunit being synthesized in the same cell transformed by at least one cell expression vector having heterologous DNA encoding each subunit with each subunit being controlled by a separate promoter. Preferred human fertility hormones include hCG, hLH and hFSH.
    Patent expiration dates:
    • June 16, 2015
      ✓ 
      Drug substance

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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