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Last Updated: July 24, 2021

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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 sixty-one patent family members in thirty-four 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 Submissiondate
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>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 8,802,628

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073075 ⤷  Free Forever Trial
Australia 2009282446 ⤷  Free Forever Trial
Brazil PI0917807 ⤷  Free Forever Trial
Canada 2732892 ⤷  Free Forever Trial
Canada 2770077 ⤷  Free Forever Trial
Chile 2011000314 ⤷  Free Forever Trial
China 102186490 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Harvard Business School
McKinsey
AstraZeneca
Merck

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