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Generic Fycompa Availability

Fycompa is a brand name of perampanel, approved by the FDA in the following formulation(s):

FYCOMPA (perampanel - suspension;oral)

  • Manufacturer: EISAI INC
    Approval date: April 29, 2016
    Strength(s): 0.5MG/ML [RLD]

FYCOMPA (perampanel - tablet;oral)

  • Manufacturer: EISAI INC
    Approval date: October 22, 2012
    Strength(s): 2MG, 4MG, 6MG, 8MG, 10MG, 12MG [RLD]

Has a generic version of Fycompa been approved?

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

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

  • 1,2-dihydropyridine compounds, process for preparation of the same and use thereof
    Patent 6,949,571
    Issued: September 27, 2005
    Inventor(s): Nagato; Satoshi & Ueno; Kohshi & Kawano; Koki & Norimine; Yoshihiko & Ito; Koichi & Hanada; Takahisa & Ueno; Masataka & Amino; Hiroyuki & Ogo; Makoto & Hatakeyama; Shinji & Groom; Anthony John & Rivers; Leanne & Smith; Terence
    Assignee(s): Eisai Co., Ltd.
    The present invention provides a novel compound having an excellent AMPA receptor inhibitory action and/or kainate inhibitory action. A compound represented by the following formula, a salt thereof or hydrates thereof. In the formula, Q indicates NH, O or S; and R1, R2, R3, R4 and R5 are the same as or different from each other and each indicates hydrogen atom, a halogen atom, a C1-6 alkyl group or a group represented by the formula —X-A (wherein X indicates a single bond, an optionally substituted C1-6 alkylene group etc.; and A indicates an optionally substituted C6-14 aromatic hydrocarbocyclic group or 5- to 14-membered aromatic heterocyclic group etc.).
    Patent expiration dates:
    • June 8, 2021
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      Patent use: TREATMENT OF EPILEPSY
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      Drug substance
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      Drug product
  • Method for producing 1, 2-dihydropyridine-2-one compound
    Patent 8,772,497
    Issued: July 8, 2014
    Assignee(s): Eisai R&D Management Co., Ltd.
    The present inventions provide a method for commercially producing a 1,2-dihydropyridine-2-one compound represented by the following formula (III-a) wherein the ring A represents an optionally substituted 2-pyridyl group, the ring B represents an optionally substituted phenyl group, and the ring C represents an optionally substituted phenyl group. Further, the invention provides crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one and production processes therefore.
    Patent expiration dates:
    • May 16, 2026
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      Drug substance

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:
    • October 22, 2017 - NEW CHEMICAL ENTITY
    • June 19, 2018 - ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC (PG TC) SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER.

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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