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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
AstraZeneca
QuintilesIMS
UBS
Johnson and Johnson
Chinese Patent Office
McKinsey
Teva
US Army

Generated: April 26, 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 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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 8,802,628

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Healthtrust
Boehringer Ingelheim
QuintilesIMS
Chinese Patent Office
Express Scripts
Moodys
Harvard Business School
Fuji

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