Generic Follistim AQ Availability

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

FOLLISTIM AQ (follitropin alfa/beta - injectable;subcutaneous)

  • Manufacturer: ORGANON USA INC
    Approval date: March 23, 2004
    Strength(s): 300 IU/0.36ML [RLD], 600 IU/0.72ML [RLD]
  • Manufacturer: ORGANON USA INC
    Approval date: February 11, 2005
    Strength(s): 900 IU/1.08ML [RLD]
  • Manufacturer: ORGANON USA INC
    Approval date: August 26, 2005
    Strength(s): 75 IU/0.5ML [RLD], 150 IU/0.5ML [RLD]

Has a generic version of Follistim AQ been approved?

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

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

  • 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
  • Liquid gonadotropin containing formulations
    Patent 5,929,028
    Issued: July 27, 1999
    Inventor(s): Skrabanja; Arnold Titus Philip & van den Oetelaar; Petrus Johannes Maria
    Assignee(s): Akzo Nobel, N.V.
    The invention concerns a liquid gonadotropin-containing formulation characterised in that the formulation comprises a gonadotropin and stabilising amounts of a polycarboxylic acid or a salt thereof and of a thioether compound. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with the particular stabilizers in an aqueous solution. The preparations contain a sufficient amount of the polycarboxylic acid or a salt thereof, preferably sodium citrate, and a sufficient amount of the thioether compound, preferably methionine, to stabilize the protein. The preparations preferably also include a nonreducing disaccharide like sucrose, and a non-ionic surfactant.
    Patent expiration dates:
    • January 14, 2018
      ✓ 
      Patent use: TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN
      ✓ 
      Drug product
    • January 14, 2018
      ✓ 
      Patent use: METHOD OF TREATING INFERTILITY
      ✓ 
      Drug product
  • 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
  • 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
      ✓ 
      Patent use: METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN
    • August 23, 2019
      ✓ 
      Patent use: A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE OR TESTICULAR STIMULATION IN THE HUMAN
    • August 23, 2019
      ✓ 
      Patent use: METHOD OF TREATING INFERTILITY

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 22, 2014 - NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC SPERM INJECTION (ICSI) CYCLE

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.
Hide
(web5)