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Details for Patent: 8,022,095

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Which drugs does patent 8,022,095 protect, and when does it expire?

Patent 8,022,095 protects TREXIMET and is included in one NDA.

Protection for TREXIMET has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixteen patent family members in eleven countries.

Summary for Patent: 8,022,095

Title:	Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs
Abstract:	The invention is directed to methods and compositions that can be used in the treatment of headaches. In particular, methods and compositions are described involving the combination of a long-acting NSAID and a 5-HT1.sub.B/1.sub.D agonist.
Inventor(s):	Plachetka; John R. (Chapel Hill, NC)
Assignee:	Pozen, Inc. (Chapel Hill, NC)
Application Number:	10/414,493
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,022,095
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Drugs Protected by US Patent 8,022,095

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 Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes

Non-Orange Book US Patents Family Members for Patent 8,022,095

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
5,872,145	Formulation of 5-HT agonist and NSAID for treatment of migraine
6,586,458	Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs
6,060,499	Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs

International Family Members for US Patent 8,022,095

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Portugal	957914
Japan	2005325143
Japan	2002255855
Japan	3712420