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Last Updated: December 7, 2022

Details for Patent: 8,716,338


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Which drugs does patent 8,716,338 protect, and when does it expire?

Patent 8,716,338 protects ORKAMBI and is included in two NDAs.

This patent has fourteen patent family members in fourteen countries.

Summary for Patent: 8,716,338
Title:Dosage units 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 formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Inventor(s): Young; Christopher (Waltham, MA)
Assignee: Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:12/568,717
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Use; Device;

Drugs Protected by US Patent 8,716,338

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 See Plans and Pricing See Plans and Pricing Y TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338 See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE. See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338 See Plans and Pricing
>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 8,716,338

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073709 See Plans and Pricing
Australia 2009296271 See Plans and Pricing
Brazil PI0919550 See Plans and Pricing
Canada 2736545 See Plans and Pricing
Chile 2011000642 See Plans and Pricing
China 102164587 See Plans and Pricing
European Patent Office 2349223 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Mallinckrodt
McKesson
Express Scripts
Dow

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