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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 two suppliers. 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-nine 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 list2
Drug Prices: :see details

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, 2000RXYes5,985,850Aug 11, 2015Y
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,792,753Aug 11, 2015
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,914,322Aug 11, 2015
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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, 20005,852,002<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,792,753<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
6,194,392 Treatment of conditions and disease<disabled in preview>
5,990,096 Formulations containing hyaluronic acid<disabled in preview>
5,932,560 Treatment of conditions and disease<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
Israel104796<disabled in preview>
Slovakia459890<disabled in preview>
European Patent Office0952855<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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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