Generic Firmagon Availability
FIRMAGON (degarelix acetate - powder;subcutaneous)
Approval date: December 24, 2008
Strength(s): EQ 80MG BASE/VIAL, EQ 120MG BASE/VIAL [RLD]
Has a generic version of Firmagon been approved?
No. There is currently no therapeutically equivalent version of Firmagon available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Firmagon. 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.
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.
Issued: July 20, 1999
Inventor(s): Semple; Graeme & Jiang; Guangcheng
Assignee(s): Ferring BV
Peptides are provided which have improved duration of GnRH antagonistic properties. These antagonists may be used to regulate fertility and to treat steroid-dependent tumors and for other short-term and long-term treatment indications. These antagonists have a derivative of aminoPhe or its equivalent in the 5- and/or 6-positions. This derivative contains a carbamoyl group or a heterocycle including a urea in its side chain. Particularly effective decapeptides, which continue to exhibit very substantial suppression of LH secretion at 96 hours following injection, have the formulae: Ac-D-2Nal-D-4Cpa-D-3Pal-Ser-4Aph(hydroorotyl)-D-4Aph(acetyl)-Leu-Lys(isopr opyl)-Pro-D-Ala-NH.sub.2, and Ac-D-2Nal-D-4Cpa-D-3Pal-Ser-4Aph(hydroorotyl)-D-4Amf(Q.sub.2)-Leu-Lys(isop ropyl)-Pro-D-Ala-NH.sub.2, wherein Q.sub.2 is Cbm or MeCbm.Patent expiration dates:
- May 18, 2021✓✓✓
- May 18, 2021
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:
- December 24, 2013 - NEW CHEMICAL ENTITY
- Firmagon Consumer Information (Drugs.com)
- Firmagon Consumer Information (Cerner Multum)
- Firmagon AHFS DI Monographs (ASHP)
- Degarelix Consumer Information (Drugs.com)
- Degarelix acetate Consumer Information (Wolters Kluwer)
- Degarelix Consumer Information (Cerner Multum)
- Degarelix Subcutaneous Advanced Consumer Information (Micromedex)
- Degarelix Acetate AHFS DI Monographs (ASHP)
|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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.|