Generic Gonal-f RFF Pen Availability

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

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

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

  • Manufacturer: EMD SERONO
    Approval date: May 25, 2004
    Strength(s): 300 IU/0.5ML [RLD], 450 IU/0.75ML [RLD], 900 IU/1.5ML [RLD]

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

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gonal-f RFF Pen. 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
  • FSH formulation
    Patent 7,446,090
    Issued: November 4, 2008
    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
      ✓ 
      Drug product
  • Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
    Patent 7,741,268
    Issued: June 22, 2010
    Inventor(s): Samaritani; Fabrizio & Donati; Piergiorgio
    Assignee(s): Ares Trading S.A.
    The invention relates to the field of pharmaceutical formulations of follicle-stimulating hormone (FSH), luteinising hormone (LH), and mixtures of FSH and luteinising hormone (LH), and to methods of producing such formulations. The invention provides a liquid or freeze-dried formulation of FSH, or LH, or FSH and LH comprising a surfactant selected from Pluronic® F77, Pluronic F87, Pluronic F88 and Pluronic F68.
    Patent expiration dates:
    • April 2, 2024
      ✓ 
      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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