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Profile for Tradename: SOLARAZE

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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 eigthy-five patent family members in thirty-two countries.

The generic ingredient in SOLARAZE is diclofenac sodium. There are forty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There are two 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 list6

Pharmacology for Tradename: SOLARAZE

Clinical Trials for: SOLARAZE

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Status: Completed Condition: Healthy

Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
Status: Completed Condition: Photosensitivity Disorders

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Status: Recruiting Condition: Actinic Keratosis

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Status: Completed Condition: Ankle Sprain

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Status: Completed Condition: Pain

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
Status: Completed Condition: Primary Dysmenorrhea

Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta
Status: Completed Condition: Non-steroidal Anti-inflammatory Poisoning

Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
Status: Completed Condition: Impacted Third Molar Tooth

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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

These historical archives are available as an add-on to one-year subscriptions

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, 20005,929,048<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
6,114,314 Formulations containing hyaluronic acid<disabled in preview>
5,972,906 Treatment of mucous membrane disease, trauma or condition and for the relief of pain thereof<disabled in preview>
6,022,866 Use of hyaluronic acid and forms to prevent arterial restenosis<disabled in preview>
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International Patent Family for Tradename: SOLARAZE

Country Document Number Publication Date
India181289May 02, 1998
Germany69303931Jan 09, 1997
Mexico9300904Oct 01, 1993
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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