Last Updated: August 10, 2026

Details for Patent: 8,580,304


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Which drugs does patent 8,580,304 protect, and when does it expire?

Patent 8,580,304 protects MEKINIST and is included in one NDA.

Protection for MEKINIST has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-four patent family members in thirty-seven countries.

Summary for Patent: 8,580,304
Title:Pharmaceutical composition
Abstract:Disclosed are novel pharmaceutical compositions containing N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
Inventor(s):Douglas J. DeMARINI, Francisco Henriquez, Ngocdiep T. LE, Lihong Wang
Assignee: Novartis Pharma AG , GlaxoSmithKline LLC , Novartis Pharmaceuticals Corp
Application Number:US13/330,949
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,580,304
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

error: insufficient information

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Drugs Protected by US Patent 8,580,304

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX 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 Y ⤷  Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,580,304

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 084102 ⤷  Start Trial
Argentina 122185 ⤷  Start Trial
Australia 2011349422 ⤷  Start Trial
Brazil 112013015602 ⤷  Start Trial
Canada 2822701 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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