Cotellic Patent Expiration

Cotellic is a drug owned by Genentech Inc. It is protected by 13 US drug patents filed from 2015 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 30, 2036. Details of Cotellic's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7803839 Azetidines as MEK inhibitors for the treatment of proliferative diseases
Nov, 2029

(5 years from now)

Active
US10478400 Immediate-release tablets containing combimetinib and methods of making and using the same
Jun, 2036

(11 years from now)

Active
US11254649 Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Jun, 2036

(11 years from now)

Active
US10590102 Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Jun, 2036

(11 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11597699 MEK inhibitors and methods of their use
Oct, 2026

(2 years from now)

Active
US8362002 Azetidines as MEK inhibitors for the treatment of proliferative diseases
Oct, 2026

(2 years from now)

Active
US8362002

(Pediatric)

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Apr, 2027

(2 years from now)

Active
US7803839

(Pediatric)

Azetidines as MEK inhibitors for the treatment of proliferative diseases
May, 2030

(5 years from now)

Active
US11087354 Combination therapies
Jun, 2034

(9 years from now)

Active
US11087354

(Pediatric)

Combination therapies
Dec, 2034

(10 years from now)

Active
US10478400

(Pediatric)

Immediate-release tablets containing combimetinib and methods of making and using the same
Dec, 2036

(12 years from now)

Active
US11254649

(Pediatric)

Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Dec, 2036

(12 years from now)

Active
US10590102

(Pediatric)

Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Dec, 2036

(12 years from now)

Active


FDA has granted several exclusivities to Cotellic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cotellic, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cotellic.

Exclusivity Information

Cotellic holds 7 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Cotellic's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 10, 2020
Orphan Drug Exclusivity(ODE) Nov 10, 2022
Orphan Drug Exclusivity(ODE-101) Nov 10, 2022
M(M-278) Jul 28, 2025
New Indication(I-902) Oct 28, 2025
Pediatric Exclusivity(PED) Jan 28, 2026
Orphan Drug Exclusivity(ODE-416) Oct 28, 2029

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Several oppositions have been filed on Cotellic's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Cotellic's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cotellic patents.

Cotellic's oppositions filed in EPO

Cotellic has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 05, 2012, by Eip Limited. This opposition was filed on patent number EP06825554A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP13753131A Mar, 2020 Sandoz AG Opposition rejected
EP06825554A Jan, 2012 EIP Limited Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Cotellic is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cotellic's family patents as well as insights into ongoing legal events on those patents.

Cotellic's family patents

Cotellic has patent protection in a total of 42 countries. It's US patent count contributes only to 16.9% of its total global patent coverage. Click below to unlock the full patent family tree for Cotellic.

Family Patents

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Generic Launch

Generic Release Date:

Cotellic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 30, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Cotellic Generics:

There are no approved generic versions for Cotellic as of now.





About Cotellic

Cotellic is a drug owned by Genentech Inc. It is used for the treatment of adult patients with histiocytic neoplasms and melanoma. Cotellic uses Cobimetinib Fumarate as an active ingredient. Cotellic was launched by Genentech Inc in 2015.

Market Authorisation Date:

Cotellic was approved by FDA for market use on 10 November, 2015.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Cotellic is 10 November, 2015, its NCE-1 date is estimated to be 28 January, 2025

Active Ingredient:

Cotellic uses Cobimetinib Fumarate as the active ingredient. Check out other Drugs and Companies using Cobimetinib Fumarate ingredient

Treatment:

Cotellic is used for the treatment of adult patients with histiocytic neoplasms and melanoma.

Dosage:

Cotellic is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 20MG BASE TABLET Prescription ORAL