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SOLARAZE Drug Profile

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Solaraze is a drug marketed by Fougera Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-seven patent family members in thirty-three countries.

The generic ingredient in SOLARAZE is diclofenac sodium. There are forty-six drug master file entries for this compound. Seventy-six suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for Tradename: SOLARAZE

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: SOLARAZE

Clinical Trials for: SOLARAZE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,985,850<disabled>Y <disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,792,753<disabled> <disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,914,322<disabled> <disabled>
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Expired Patents for Tradename: SOLARAZE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,639,738<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,914,322<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,985,850<disabled>
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Paragraph IV activity for: SOLARAZE

Drugname Dosage Strength RLD Submissiondate
diclofenac sodiumTopical Gel3%Solaraze12/16/2009

Non-Orange Book Patents for Tradename: SOLARAZE

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
6,087,344 Formulations containing hyaluronic acid<disabled in preview>
5,910,489 Topical composition containing hyaluronic acid and NSAIDS<disabled in preview>
5,942,498 Formulations containing hyaluronic acid<disabled in preview>
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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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International Patent Family for Tradename: SOLARAZE

Country Document Number Estimated Expiration
Hungary225967<disabled in preview>
Hungary9500857<disabled in preview>
Romania117499<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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