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Last Updated: January 27, 2020

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COTELLIC Drug Profile

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Which patents cover Cotellic, and when can generic versions of Cotellic launch?

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

This drug has fifty-seven patent family members in thirty-one 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.

US ANDA Litigation and 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 February 1, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COTELLIC
Drug patent expirations by year for COTELLIC
Drug Prices for COTELLIC

See drug prices for COTELLIC

Generic Entry Opportunity 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
Uppsala University HospitalPhase 2
Texas Children's HospitalPhase 2
Carl AllenPhase 2

See all COTELLIC clinical trials

Pharmacology for COTELLIC
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
Synonyms for COTELLIC
(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl)(3-hydroxy-3-((S)-piperidin-2-yl)cyclobutyl)methanone
(S)-(3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)phenyl)(3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl)methanone
(S)-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl)(3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl)methanone
[3,4-Bis(Fluoranyl)-2-[(2-Fluoranyl-4-Iodanyl-Phenyl)amino]phenyl]-[3-Oxidanyl-3-[(2s)-Piperidin-2-Yl]azetidin-1-Yl]methanone
[3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-phenyl]-((s)-3-hydroxy-3-piperidin-2-yl-azetidin-1-yl)-methanone
[3,4-difluoro-2-(2-fluoro-4-iodoanilino)phenyl]{3-hydroxy-3-[(2S)-piperidin-2-yl]azetidin-1-yl}methanone
[3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl]-[3-hydroxy-3-[(2S)-piperidin-2-yl]azetidin-1-yl]methanone
[3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl][3-hydroxy-3-[(2S)-2-piperidinyl]-1-azetidinyl]methanone
{3,4-difluoro-2-[(2-fluoro-4-iodophenyl)amino]phenyl}{3-hydroxy-3-[(2S)-piperidin-2-yl]azetidin-1-yl}methanone
1029872-29-4
1369665-02-0
3556AH
6EXI96H8SV
934660-93-2
AB0072274
AK173907
AKOS025396263
BC600781
BCP9000716
BDBM50391802
bis[(2S)-2-{1-[3,4-difluoro-2-(2-fluoro-4-iodoanilino)benzoyl]-3-hydroxyazetidin-3-yl}piperidin-1-ium] (2E)-but-2-enedioate
BSMCAPRUBJMWDF-KRWDZBQOSA-N
C21H21F3IN3O2
CHEBI:90851
CHEBI:90853
CHEMBL2146883
CHEMBL2364607
Cobimetinib
Cobimetinib (GDC-0973, RG7420)
Cobimetinib (USAN/INN)
Cobimetinib [USAN:INN]
Cobimetinib Butyrate
Cobimetinib Fumarate
Cobimetinib fumarate (USAN)
Cobimetinib fumarate [USAN]
Cobimetinib hemifumarate
cometinib
Cotellic (TN)
CS-0521
D10405
D10615
DB05239
DTXSID60239435
ER29L26N1X
EUI
EX-A673
FT-0675878
GDC 0973
GDC-0973
GDC-0973 hemifumarate
GDC0973
GDC0973; XL518; Cobimetinib
GTPL7626
HY-13064
J-525162
KB-77527
KS-0000059E
Methanone, (3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)phenyl)(3-hydroxy-3-((2S)-2-piperidinyl)-1-azetidinyl)-
Methanone, (3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)phenyl)(3-hydroxy-3-(2S)-2-piperidinyl-1-azetidinyl)-, (2E)-2-butenedioate (2:1)
MolPort-028-720-358
NCGC00346455-03
QCR-87
RG 7420
RG-7421
RG7420
s8041
SCHEMBL189565
UNII-6EXI96H8SV
UNII-ER29L26N1X
W-5863
XL 518
Xl-518
Xl-518 hemifumarate
XL518
ZINC60325170

US Patents and Regulatory Information for COTELLIC

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

Supplementary Protection Certificates for COTELLIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1934174 C01934174/01 Switzerland   Start Trial PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015
1934174 16C0021 France   Start Trial PRODUCT NAME: COBIMETINIB,OPTIONNELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE,NOTAMMENT SES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'HEMIFUMARATE DE COBIMETINIB; REGISTRATION NO/DATE: EU/1/15/1048 20151124
1934174 C20160012 00193 Estonia   Start Trial PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
1934174 93078 Luxembourg   Start Trial PRODUCT NAME: COBIMETINIB, EVENTUELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE, Y COMPRIS LES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER HEMIFUMARATE DE COBIMETINIB; FIRST REGISTRATION DATE: 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Mallinckrodt
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Harvard Business School
Merck

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