Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Boehringer Ingelheim
Harvard Business School
Colorcon
McKinsey

Last Updated: February 28, 2020

DrugPatentWatch Database Preview

MEKINIST Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

When do Mekinist patents expire, and what generic alternatives are available?

Mekinist is a drug marketed by Novartis and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.

US ANDA Litigation and Generic Entry Outlook for Mekinist

Mekinist was eligible for patent challenges on May 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 28, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

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

See drug prices for MEKINIST

Generic Entry Opportunity Date for MEKINIST
Generic Entry Date for MEKINIST*:
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 MEKINIST

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

SponsorPhase
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
Novartis PharmaceuticalsPhase 4
Manisha ShahPhase 1

See all MEKINIST clinical trials

Pharmacology for MEKINIST
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for MEKINIST
1204531-14-5
33E86K87QN
4CA-0583
871700-17-3
A1-01871
A25168
AB0008115
ABP000312
AC-25891
Acetamide, N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-3,4,6,7-tetrahydro-6,8- dimethyl-2,4,7-trioxopyrido(4,3-d)pyrimidin-1(2H)-yl)phenyl)-
Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-
AK174783
AKOS015850628
AM90271
AN-539
AOB87707
AS-19382
BC638742
BCP02307
BCPP000218
BRD-K12343256-001-01-4
C26H23FIN5O4
cc-37
CHEBI:75998
CHEMBL2103875
CS-0060
D10175
DB08911
EX-5957
EX-A022
FT-0688438
GSK 1120212
GSK-1120212
GSK-1120212/GSK1120212/
GSK1120212
GSK1120212 - JTP-74057
GSK1120212 (Trametinib)
GSK1120212,JTP-74057, GSK212
GSK212
GTPL6495
HMS3656J11
HY-10999
J-523325
JTP 74057
JTP-74057
JTP-74057, 871700-17-3
KB-52302
KS-00000002
LIRYPHYGHXZJBZ-UHFFFAOYSA-N
MolPort-019-879-136
N-(3-(3-Cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- tetrahydropyrido(4,3-d)pyrimidin-1(2H)-yl)phenyl)acetamide
N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2H)-yl)phenyl)acetamide
N-(3-{3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- tetrahydropyrido(4,3-d)pyrimidin-1(2H)-yl}phenyl)acetamide
N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2H)-yl}phenyl)acetamide
N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl}phenyl)acetamide
N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodo-anilino)-6,8-dimethyl-2,4,7-trioxo-pyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide
N-[3-[3-Cyclopropyl-5-[(2-fluoro-4-iodophenyl)amin
n-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyr
N-[3-[3-Cyclopropyl-5-[(2-Fluoro-4-Iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phe nyl]acetamide
N-[3-[3-Cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]acetamide
N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxopyrido[3,4-e]pyrimidin-1-yl]phenyl]acetamide
N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide
NCGC00263180-01
NCGC00263180-07
QCR-39
RL05418
RW4149
S-7800
s2673
SB16553
SC-85458
SCHEMBL170938
SR-01000941589
SR-01000941589-1
SW218089-2
TMT212
Trametinib
Trametinib (GSK-1120212)
Trametinib (GSK1120212)
Trametinib (GSK1120212JTP 74057)
Trametinib (USAN)
Trametinib [USAN:INN]
Trametinib; JTP 74057
trametinibum
UNII-33E86K87QN
X7454
ZINC43100709

US Patents and Regulatory Information for MEKINIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No   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 MEKINIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 68/2014 Austria   Start Trial PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528 1490063-3 Sweden   Start Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
1761528 132014902315090 Italy   Start Trial PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Boehringer Ingelheim
Moodys
Medtronic
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.