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Generic Cotellic Availability

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

COTELLIC (cobimetinib fumarate - tablet;oral)

  • Manufacturer: GENENTECH INC
    Approval date: November 10, 2015
    Strength(s): EQ 20MG BASE [RLD]

Has a generic version of Cotellic been approved?

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

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

  • Azetidines as MEK inhibitors for the treatment of proliferative diseases
    Patent 7,803,839
    Issued: September 28, 2010
    Inventor(s): Aay; Naing & Anand; Neel Kumar & Blazey; Charles M. & Bowles; Owen Joseph & Bussenius; Joerg & Costanzo; Simona & Curtis; Jeffry Kimo & DeFina; Steven Charles & Dubenko; Larisa & Joshi; Anagha Abhijit & Kennedy; Abigail R. & Kim; Angie Inyoung & Koltun; Elena S. & Manalo; Jean-Cla
    Assignee(s): Exelixis, Inc.
    Disclosed are compounds of Formula (I) and pharmaceutically acceptable salts and solvates thereof. Such compounds are MEK inhibitors and are useful in the treatment of proliferative diseases, such as cancer. Also disclosed are pharmaceutical compositions containing such compounds as well as methods of using the compounds and compositions of the invention in the treatment of cancer.
    Patent expiration dates:
    • February 1, 2027
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      Drug substance
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      Drug product
  • Azetidines as MEK inhibitors for the treatment of proliferative diseases
    Patent 8,362,002
    Issued: January 29, 2013
    Assignee(s): Exelixis, Inc.
    Disclosed are compounds of Formula (I) and pharmaceutically acceptable salts and solvates thereof. Such compounds are MEK inhibitors and are useful in the treatment of proliferative diseases, such as cancer. Also disclosed are pharmaceutical compositions containing such compounds as well as methods of using the compounds and compositions of the invention in the treatment of cancer.
    Patent expiration dates:
    • October 5, 2026
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      Patent use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

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:
    • November 10, 2020 - NEW CHEMICAL ENTITY
    • November 10, 2022 - ORPHAN DRUG EXCLUSIVITY

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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