BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Healthtrust
Farmers Insurance
Boehringer Ingelheim
Covington
Queensland Health
Cantor Fitzgerald
Fish and Richardson
Harvard Business School

Generated: January 23, 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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE. ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,716,338

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Taiwan 201034668 ➤ Subscribe
Russian Federation 2011117177 ➤ Subscribe
Mexico 2011003249 ➤ Subscribe
South Korea 20110063578 ➤ Subscribe
Japan 2012504143 ➤ Subscribe
Israel 212025 ➤ Subscribe
European Patent Office 2349223 ➤ Subscribe
China 102164587 ➤ Subscribe
Canada 2736545 ➤ Subscribe
Australia 2009296271 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Covington
Harvard Business School
Accenture
McKesson
Federal Trade Commission
Deloitte
Argus Health
Cantor Fitzgerald
Cerilliant

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 verifification 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.

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