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Last Updated: October 14, 2024

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COTELLIC Drug Patent Profile


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Which patents cover Cotellic, and what generic alternatives are available?

Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and eighty-two patent family members in forty-three countries.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Cotellic

Cotellic was eligible for patent challenges on November 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COTELLIC
International Patents:182
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 10
Clinical Trials: 35
Patent Applications: 1
Drug Prices: Drug price information for COTELLIC
What excipients (inactive ingredients) are in COTELLIC?COTELLIC excipients list
DailyMed Link:COTELLIC at DailyMed
Drug patent expirations by year for COTELLIC
Drug Prices for COTELLIC

See drug prices for COTELLIC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COTELLIC
Generic Entry Date for COTELLIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COTELLIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of BirminghamPhase 2/Phase 3
Cancer Research UKPhase 2/Phase 3
Royal Marsden NHS Foundation TrustPhase 2/Phase 3

See all COTELLIC clinical trials

Pharmacology for COTELLIC
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for COTELLIC

COTELLIC is protected by seven US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COTELLIC is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COTELLIC

Immediate-release tablets containing combimetinib and methods of making and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AS A SINGLE AGENT FOR THE TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting COTELLIC

TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷  Sign Up

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for COTELLIC

When does loss-of-exclusivity occur for COTELLIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5483
Patent: SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODOFENILAMINO)FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL)AZETIDIN-1-IL]-METANONA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 16288209
Patent: Crystalline fumarate salt of (S)-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl) (3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl)-methanone
Estimated Expiration: ⤷  Sign Up

Patent: 21200202
Patent: CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017028516
Patent: sal de fumarato cristalino de (s)-[3,4-difluoro-2-(2-fluoro-4-iodofenilamino)fenil][3-hidroxi-3-(piperidin-2-il) azetidin-1-il]-metanona
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 90222
Patent: SEL CRISTALLIN DE FUMARATE DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL][3-HYDROXY-3-(PIPERIDIN-2-YL)AZETIDIN-1-YL]-METHANONE (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17003475
Patent: Sal de fumarato cristalina de (s)-[3,4-difluoro-2-(2-fluoro-4-yodofenilamino)fenil][3-hidroxi-3-(piperidin-2-il)azetidin-1-il]-metanona
Estimated Expiration: ⤷  Sign Up

China

Patent: 7810183
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 18000086
Patent: Sal de fumarato cristalina de (s)-[3,4-difluoro-2-(2-fluoro-4-yodofenilamino)fenil][3-hidroxi-3-(piperidin-2-il)azetidin-1-il]-metanona
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 180056
Patent: SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODOFENILAMINO)FENIL] [3-HIDROXI-3-(PIPERIDIN-2-IL)AZETIDIN-1-IL]-METANONA
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 17264
Patent: SEL CRISTALLIN DE FUMARATE DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHÉNYLAMINO)PHÉNYL][3-HYDROXY-3-(PIPÉRIDIN-2-YL)AZÉTIDIN-1-YL]-MÉTHANONE (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL][3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 52433
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6423
Patent: מלח פומראט גבישי של (s (-[4,3-דיפלואורו-2-(2-פלואורו-4-יודופנילאמינו)פניל] [3-הידרוקסי-3-(פיפרידין-2-איל)אזטידין-1-איל]-מתאנון (Crystalline fumarate salt of (s)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone)
Estimated Expiration: ⤷  Sign Up

Patent: 5052
Patent: מלח פומראט גבישי של (s)-[4,3-דיפלואורו-2-(2-פלואורו-4-יודופנילאמינו)פניל] [3-הידרוקסי-3-(פיפרידין-2-איל)אזטידין-1-איל]-מתאנון (Crystalline fumarate salt of (s)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 38950
Estimated Expiration: ⤷  Sign Up

Patent: 18519318
Patent: (S)−[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードフェニルアミノ)フェニル][3−ヒドロキシ−3−(ピペリジン−2−イル」)アゼチジン−1−イル]−メタノンの結晶性フマル酸塩
Estimated Expiration: ⤷  Sign Up

Patent: 21035967
Patent: (S)−[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードフェニルアミノ)フェニル][3−ヒドロキシ−3−(ピペリジン−2−イル)アゼチジン−1−イル]−メタノンの結晶性フマル酸塩 (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Estimated Expiration: ⤷  Sign Up

Patent: 23025000
Patent: (S)-[3,4-ジフルオロ-2-(2-フルオロ-4-ヨードフェニルアミノ)フェニル][3-ヒドロキシ-3-(ピペリジン-2-イル)アゼチジン-1-イル]-メタノンの結晶性フマル酸塩
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2545
Patent: CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17017037
Patent: SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODO FENILAMINO) FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL]AZETIDIN-1-IL]-META NONA. (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODO PHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 301
Patent: SEL CRISTALLIN DE FUMARATE DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHÉNYLAMINO)PHÉNYL][3-HYDROXY-3-(PIPÉRIDIN-2-YL)AZÉTIDIN-1-YL]-MÉTHANONE
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 180692
Patent: SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODOFENILAMINO)FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL)AZETIDIN-1-IL]-METANONA
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017502414
Patent: CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 62181
Patent: КРИСТАЛЛИЧЕСКАЯ ФУМАРАТНАЯ СОЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНИЛАМИНО)ФЕНИЛ][3-ГИДРОКСИ-3-(ПИПЕРИДИН-2-ИЛ)АЗЕТИДИН-1-ИЛ]МЕТАНОНА (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL][3-HYDROXY-3-(PIPERIDINE-2-YL)AZETIDINE-1-YL]METHANONE)
Estimated Expiration: ⤷  Sign Up

Patent: 18103172
Patent: КРИСТАЛЛИЧЕСКАЯ ФУМАРАТНАЯ СОЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНИЛАМИНО)ФЕНИЛ][3-ГИДРОКСИ-3-(ПИПЕРИДИН-2-ИЛ)АЗЕТИДИН-1-ИЛ]МЕТАНОНА
Estimated Expiration: ⤷  Sign Up

Patent: 21132394
Patent: КРИСТАЛЛИЧЕСКАЯ ФУМАРАТНАЯ СОЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНИЛАМИНО)ФЕНИЛ][3-ГИДРОКСИ-3-(ПИПЕРИДИН-2-ИЛ)АЗЕТИДИН-1-ИЛ]МЕТАНОНА
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202105196Y
Patent: CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1708760
Patent: CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 180021775
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 10556
Estimated Expiration: ⤷  Sign Up

Patent: 75187
Estimated Expiration: ⤷  Sign Up

Patent: 1718535
Patent: Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Estimated Expiration: ⤷  Sign Up

Patent: 2108568
Patent: Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4728
Patent: КРИСТАЛІЧНА ФУМАРАТНА СІЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНІЛАМІНО)ФЕНІЛ][3-ГІДРОКСИ-3-(ПІПЕРИДИН-2-ІЛ)АЗЕТИДИН-1-ІЛ]МЕТАНОНУ (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COTELLIC around the world.

Country Patent Number Title Estimated Expiration
France 16C0021 ⤷  Sign Up
Chile 2015000345 Uso de una combinación para el melanoma que comprende la administración de cobimetinib y vemurafenib. ⤷  Sign Up
Japan 2019089841 MEKインヒビターおよびその使用方法 (MEK INHIBITOR AND APPLICATION METHOD THEREOF) ⤷  Sign Up
Japan 2018519305 薬物を含有する即放性錠剤及び錠剤の形成プロセス ⤷  Sign Up
Australia 2006302415 Azetidines as MEK inhibitors for the treatment of proliferative diseases ⤷  Sign Up
Israel 256423 מלח פומראט גבישי של (s (-[4,3-דיפלואורו-2-(2-פלואורו-4-יודופנילאמינו)פניל] [3-הידרוקסי-3-(פיפרידין-2-איל)אזטידין-1-איל]-מתאנון (Crystalline fumarate salt of (s)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone) ⤷  Sign Up
Australia 2016287422 Immediate-release tablets containing a drug and processes for forming the tablets ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COTELLIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1934174 PA2016016 Lithuania ⤷  Sign Up PRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174 132016000050893 Italy ⤷  Sign Up PRODUCT NAME: COBIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE, INCLUSI SALI E SOLVATI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE COBIMETINIB EMIFUMARATO(COTELLIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1048, 20151124
1934174 650 Finland ⤷  Sign Up
1934174 C201630028 Spain ⤷  Sign Up PRODUCT NAME: COBIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1048; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1048; DATE OF FIRST AUTHORISATION IN EEA: 20151120
1934174 122016000033 Germany ⤷  Sign Up PRODUCT NAME: COBIMETINIB, OPTIONAL ALS PHARMAZEUTISCH ZULAESSIGES SALZ ODER SOLVAT DAVON, INSBESONDERE COBIMETINIB-HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174 364 5005-2016 Slovakia ⤷  Sign Up PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
1934174 CR 2016 00021 Denmark ⤷  Sign Up PRODUCT NAME: COBIMETINIB OG FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER DERAF, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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