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Details for Patent: 8,802,628

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Patent 8,802,628 protects LINZESS and is included in one NDA. There has been one Paragraph IV challenge on Linzess.

This patent has thirty-three 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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXNo8,802,628► subscribeY
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYes8,802,628► subscribeY
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Non-Orange Book Patents 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
8,748,573Formulations comprising linaclotide► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,802,628

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine104870► subscribe
TaiwanI531374► subscribe
Taiwan201023874► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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