Generic Cotellic Availability
Last updated on Apr 10, 2024.
Cotellic is a brand name of cobimetinib, approved by the FDA in the following formulation(s):
COTELLIC (cobimetinib fumarate - tablet;oral)
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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: Generic Drug FAQ.
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.
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Immediate-release tablets containing combimetinib and methods of making and using the same
Patent 10,478,400
Issued: November 19, 2019
Inventor(s): Kothari Sanjeev & Mantik Priscilla & Mauerer Alexander & Rezaei Hamid
Assignee(s): Genentech, Inc.The present disclosure relates generally to rapid-release pharmaceutical dosage unit tablets containing a drug that is an inhibitor of the mitogen-activated protein kinase enzyme, a filler and a disintegrant, and to processes for forming the tablets. More specifically, the present disclosure relates to pharmaceutical dosage unit tablets containing cobimetinib, a least one filler, at least one lubricant and at least one disintegrant, and to methods for preparing the tablets from granules formed by dry granulation.
Patent expiration dates:
- June 29, 2036✓✓✓
- June 29, 2036
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Immediate-release tablets containing combimetinib and methods of making and using the same
Patent 10478400*PE
Issued: November 19, 2019
Inventor(s): Kothari Sanjeev & Mantik Priscilla & Mauerer Alexander & Rezaei Hamid
Assignee(s): Genentech, Inc.The present disclosure relates generally to rapid-release pharmaceutical dosage unit tablets containing a drug that is an inhibitor of the mitogen-activated protein kinase enzyme, a filler and a disintegrant, and to processes for forming the tablets. More specifically, the present disclosure relates to pharmaceutical dosage unit tablets containing cobimetinib, a least one filler, at least one lubricant and at least one disintegrant, and to methods for preparing the tablets from granules formed by dry granulation.
Patent expiration dates:
- December 29, 2036
- December 29, 2036
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Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Patent 10,590,102
Issued: March 17, 2020
Inventor(s): Brown Adrian St. Clair
Assignee(s): EXELIXIS, INC.This disclosure relates to the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Patent expiration dates:
- June 30, 2036✓✓✓
- June 30, 2036
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Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Patent 10590102*PE
Issued: March 17, 2020
Inventor(s): Brown Adrian St. Clair
Assignee(s): EXELIXIS, INC.This disclosure relates to the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Patent expiration dates:
- December 30, 2036
- December 30, 2036
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Combination therapies
Patent 11,087,354
Issued: August 10, 2021
Inventor(s): Bray Gordon & Chan Iris
Assignee(s): Genentech, Inc.The present invention relates generally to the fields of molecular biology and growth factor regulation. More specifically, the invention relates to therapies for the treatment of pathological conditions, such as cancer.
Patent expiration dates:
- June 22, 2034✓
- June 22, 2034
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Combination therapies
Patent 11087354*PE
Issued: August 10, 2021
Inventor(s): Bray Gordon & Chan Iris
Assignee(s): Genentech, Inc.The present invention relates generally to the fields of molecular biology and growth factor regulation. More specifically, the invention relates to therapies for the treatment of pathological conditions, such as cancer.
Patent expiration dates:
- December 22, 2034
- December 22, 2034
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Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Patent 11,254,649
Issued: February 22, 2022
Inventor(s): Brown Adrian St. Clair
Assignee(s): Exelixis, Inc.This disclosure relates to the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Patent expiration dates:
- June 30, 2036✓✓✓
- June 30, 2036
-
Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Patent 11254649*PE
Issued: February 22, 2022
Inventor(s): Brown Adrian St. Clair
Assignee(s): Exelixis, Inc.This disclosure relates to the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Patent expiration dates:
- December 30, 2036
- December 30, 2036
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Patent 11,597,699
Patent expiration dates:
- October 5, 2026✓
- October 5, 2026
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Patent 7,803,839
Patent expiration dates:
- November 10, 2029✓✓
- November 10, 2029
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Patent 7803839*PED
Patent expiration dates:
- May 10, 2030✓
- May 10, 2030
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Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent 8,362,002
Issued: January 29, 2013
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-Claire Limun & Peto
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✓
- October 5, 2026
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Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent 8362002*PED
Issued: January 29, 2013
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-Claire Limun & Peto
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:
- April 5, 2027✓
- April 5, 2027
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:
- July 28, 2025 - INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665
- October 28, 2025 - TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
- January 28, 2026 - PEDIATRIC EXCLUSIVITY
- October 28, 2029 - TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
More about Cotellic (cobimetinib)
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Glossary
Term | Definition |
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.