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Details for Patent: 8,946,292

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Patent 8,946,292 protects DYLOJECT and is included in one NDA. There has been one Paragraph IV challenge on Dyloject. There are five tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has nineteen patent family members in eleven countries.

Summary for Patent: 8,946,292

Title:Formulations of low dose diclofenac and beta-cyclodextrin
Abstract: The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 75 mg, e.g., from about 18.75 mg to about 37.5 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.
Inventor(s): Wright; Curtis (Rockport, MA), Carr; Daniel B. (Chestnut Hill, MA), Mermelstein; Fred H. (Newtown, MA)
Assignee: Javelin Pharmaceuticals, Inc. (Lake Forest, IL)
Application Number:13/106,697
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
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
Javelin Pharms Inc
DYLOJECT
diclofenac sodium
SOLUTION;INTRAVENOUS022396-001Dec 23, 2014RXYes8,946,292► subscribe MANAGEMENT OF PAIN
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Non-Orange Book Patents for Patent: 8,946,292

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
8,580,954Formulations of low dose diclofenac and beta-cyclodextrin► 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: 8,946,292

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2016040327► subscribe
South Korea20080112285► subscribe
Japan5823093► 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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