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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						TREATMENT OF INSOMNIA
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010		RX	Yes	Yes						TREATMENT OF INSOMNIA

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
9,498,462	Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders
9,801,847	Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders
9,107,898	Methods of using low-dose doxepin for the improvement of sleep

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

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2687118
Canada	2687124
European Patent Office	2026792
Japan	2009537553