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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
US Army
Harvard Business School
US Department of Justice
Queensland Health
Fish and Richardson
Citi
Cantor Fitzgerald

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,513,299

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Which drugs does patent 8,513,299 protect, and when does it expire?

Patent 8,513,299 protects SILENOR and is included in one NDA.

This patent has ten patent family members in four countries.
Summary for Patent: 8,513,299
Title:Methods of using low-dose doxepin for the improvement of sleep
Abstract: Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Inventor(s): Rogowski; Roberta L. (Rancho Santa Fe, CA), Dube; Susan E. (Carlsbad, CA), Jochelson; Philip (San Diego, CA)
Assignee: Pernix Sleep, Inc. (The Woodlands, TX) Procom One, Inc. (San Marcos, TX)
Application Number:11/804,720
Patent Claim Types:
see list of patent claims
Use;

Drugs Protected by US Patent 8,513,299

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial TREATMENT OF INSOMNIA ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial TREATMENT OF INSOMNIA ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,513,299

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
9,486,437 Methods of using low-dose doxepin for the improvement of sleep ➤ Try a Free Trial
9,498,462 Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Try a Free Trial
9,801,847 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Try a Free Trial
9,107,898 Methods of using low-dose doxepin for the improvement of sleep ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,513,299

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2687118 ➤ Try a Free Trial
Canada 2687124 ➤ Try a Free Trial
European Patent Office 2026792 ➤ Try a Free Trial
Japan 2009537553 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
Dow
Citi
Deloitte
Medtronic
Moodys
US Army
Chinese Patent Office

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