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Details for Patent: 8,246,989

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Patent 8,246,989 protects ATELVIA and is included in one NDA. There has been one Paragraph IV challenge on Atelvia. There are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has seventy-one patent family members in thirty-one countries.

Summary for Patent: 8,246,989

Title:Dosage forms of bisphosphonates
Abstract: Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and, means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.
Inventor(s): Dansereau; Richard John (Cincinnati, OH), Burgio, Jr.; David Ernest (Liberty Township, OH)
Assignee: Warner Chilcott Company, LLC (Fajardo, PR)
Application Number:12/637,100
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 43rd 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
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes8,246,989► subscribeY
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Non-Orange Book Patents for Patent: 8,246,989

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
8,535,718Dosage forms of bisphosphonates► subscribe
7,645,459Dosage forms of bisphosphonates► subscribe
7,645,460Dosage forms of risedronate► 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: 8,246,989

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina049022► subscribe
Austria475412► subscribe
Australia2005247299► 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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