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Details for Patent: 8,778,373

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Patent 8,778,373 protects RAYALDEE and is included in one NDA.

This patent has nineteen patent family members in eleven countries.

Summary for Patent: 8,778,373

Title:Methods for controlled release oral dosage of a vitamin D compound
Abstract: A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s): Bishop; Charles W. (Mount Horeb, WI), Tabash; Samir P. (Whitby, CA), Agudoawu; Sammy Asiamah (Mississauga, CA), White; Jay A. (Newmarket, CA), Crawford; Keith H. (Highlands Ranch, CO), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA)
Assignee: Opko IP Holdings II, Inc. (Grand Cayman, KY) Opko Renal, LLC (Miami, FL)
Application Number:13/746,982
Patent Claim Types:
see list of patent claims
Use; 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
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYes8,778,373► subscribe ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
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Non-Orange Book Patents for Patent: 8,778,373

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
8,361,488Methods and compositions for controlled release oral dosage of a vitamin D compound► subscribe
8,207,149Method for treating secondary hyperparathyroidism in CKD► 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: 8,778,373

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2683997► subscribe
China101668517► subscribe
China104523707► 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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