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Which drugs does patent 8,546,450 protect, and when does it expire?

Patent ► Subscribe protects PENNSAID and is included in two NDAs. There have been two Paragraph IV challenges on Pennsaid.

Summary for Patent: ► Subscribe

Title:	Treatment of pain with topical diclofenac compounds
Abstract:	The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s):	Singh; Jagat (Scarborough, CA), Shainhouse; Joseph Zev (North York, CA), Galer; Bradley S. (West Chester, PA), King-Smith; Robert Dominic (San Diego, CA), Grierson; Lisa Marie (Richmond Hill, CA), Burian; Maria (Stolberg, DE), Wilkin; Jonathan (Columbus, OH), Kisak; Edward T. (San Diego, CA), Newsam; John M. (La Jolla, CA)
Assignee:	Nuvo Research Inc. (Mississauga, Ont., CA)
Application Number:	12/459,998
Patent Claim Types: see list of patent claims	Use;

Glossary

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Patented / Exclusive Use
Horizon Pharma	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014	AT	RX	Yes	Yes	► Subscribe	► Subscribe	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
Horizon Pharma	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014	AT	RX	Yes	Yes	► Subscribe	► Subscribe	COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Nuvo Pharms Inc	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	020947-001	Nov 4, 2009		DISCN	Yes	No	► Subscribe	► Subscribe	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
Nuvo Pharms Inc	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	020947-001	Nov 4, 2009		DISCN	Yes	No	► Subscribe	► Subscribe	COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.

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Non-Orange Book Patents for Patent: ► Subscribe

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
8,217,078	Treatment of pain with topical diclofenac	► Subscribe
9,370,501	Treatment of pain with topical diclofenac	► Subscribe
8,741,956	Treatment of pain with topical diclofenac	► Subscribe
9,415,029	Treatment of pain with topical diclofenac	► Subscribe
8,618,164	Treatment of pain with topical diclofenac compounds	► Subscribe
9,132,110	Treatment of pain with topical diclofenac	► Subscribe
9,375,412	Treatment of pain with topical diclofenac	► 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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