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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Teva
Chinese Patent Office
McKinsey
Baxter
Harvard Business School
McKesson
Boehringer Ingelheim
Queensland Health

Generated: April 22, 2018

DrugPatentWatch Database Preview

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 one NDA.

This patent has twelve patent family members in twelve 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 Patent Submitted
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ➤ Sign Up ➤ Sign Up 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 ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE. ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up 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 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,716,338

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,192,606 Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Cipla
Julphar
McKinsey
Fuji
UBS
Medtronic
Fish and Richardson

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