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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Covington
UBS
Fuji
Harvard Business School
Farmers Insurance
Johnson and Johnson
Daiichi Sankyo
McKesson

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,802,628

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Which drugs does patent 8,802,628 protect, and when does it expire?

Patent 8,802,628 protects LINZESS and is included in one NDA.

This patent has thirty-nine patent family members in twenty-three countries.
Summary for Patent: 8,802,628
Title:Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Abstract: Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr ("linaclotide"; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.
Inventor(s): Fretzen; Angelika (Somerville, MA), Witowski; Steven (Melrose, MA), Grossi; Alfredo (Somerville, MA), Zhao; Hong (Lexington, MA), Dedhiya; Mahendra (Pomona, NY), Mo; Yun (Commack, NY)
Assignee: Ironwood Pharmaceuticals, Inc. (Cambridge, MA) Forest Laboratories Holdings, Ltd. (Hamilton, BM)
Application Number:12/541,410
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,802,628
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;

Drugs Protected by US Patent 8,802,628

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
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 8,802,628

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
8,748,573 Formulations comprising linaclotide ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,802,628

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073075 ➤ Try a Free Trial
Australia 2009282446 ➤ Try a Free Trial
Canada 2732892 ➤ Try a Free Trial
Canada 2770077 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fuji
McKesson
Covington
Dow
US Army
Express Scripts
Farmers Insurance
Fish and Richardson

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