SOLARAZE Drug Patent Profile

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Which patents cover Solaraze, and when can generic versions of Solaraze launch?

Solaraze is a drug marketed by Fougera Pharms and is included in one NDA.

The generic ingredient in SOLARAZE is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Solaraze

A generic version of SOLARAZE was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

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Summary for SOLARAZE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	11
Patent Applications:	3,921
What excipients (inactive ingredients) are in SOLARAZE?	SOLARAZE excipients list
DailyMed Link:	SOLARAZE at DailyMed

Drug patent expirations by year for SOLARAZE

Recent Clinical Trials for SOLARAZE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Infectopharm Arzneimittel GmbH	Phase 3
Gesellschaft für Therapieforschung mbH	Phase 3
Encube Ethicals Pvt. Ltd.	Phase 3

See all SOLARAZE clinical trials

Paragraph IV (Patent) Challenges for SOLARAZE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOLARAZE	Topical Gel	diclofenac sodium	3%	021005	1	2009-12-16

US Patents and Regulatory Information for SOLARAZE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for SOLARAZE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SOLARAZE

See the table below for patents covering SOLARAZE around the world.

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Country	Patent Number	Title	Estimated Expiration
Poland	308201		⤷ Sign Up
Slovakia	11193	FORMULATIONS CONTAINING HYALURONIC ACID	⤷ Sign Up
Norway	312939		⤷ Sign Up
Hungary	225963	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF BASAL CELL CARCINOMA AND ACTINIC KERATOSES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for SOLARAZE

Recent Clinical Trials for SOLARAZE

Paragraph IV (Patent) Challenges for SOLARAZE

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