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Last Updated: July 6, 2020

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TAFINLAR Drug Profile


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

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

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

The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Tafinlar

Tafinlar 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 October 15, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TAFINLAR
Drug Prices for TAFINLAR

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Generic Entry Opportunity Date for TAFINLAR
Generic Entry Date for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 TAFINLAR

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

SponsorPhase
JS InnoPharm, LLCPhase 1
National Cancer Institute (NCI)Phase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2

See all TAFINLAR clinical trials

US Patents and Regulatory Information for TAFINLAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   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 TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 C01761528/01 Switzerland   Start Trial PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
1761528 14C0083 France   Start Trial PRODUCT NAME: TRAMETINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL,HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/931 20140630
1761528 205 5032-2014 Slovakia   Start Trial PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
1761528 565 Finland   Start Trial
1761528 2014/063 Ireland   Start Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Baxter
McKinsey
Dow
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 verification 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.