Last Updated: July 28, 2026

Details for Patent: 8,507,534


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Which drugs does patent 8,507,534 protect, and when does it expire?

Patent 8,507,534 protects ORKAMBI and is included in two NDAs.

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

This patent has sixty patent family members in twenty-eight countries.

Summary for Patent: 8,507,534
Title:Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Abstract:The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):Ali Keshavarz-Shokri, Beili Zhang, Mariusz Krawiec
Assignee: Vertex Pharmaceuticals Inc
Application Number:US12/327,902
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,507,534
Patent Claim Types:
see list of patent claims
Composition; Compound;

Drugs Protected by US Patent 8,507,534

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-003 Sep 2, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 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 8,507,534

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2225230 ⤷  Start Trial 2017009 Norway ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 301060 Netherlands ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial PA2020525 Lithuania ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 122020000044 Germany ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial LUC00172 Luxembourg ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 2020C/005 Belgium ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial CA 2020 00039 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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