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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. 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

Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
Status: Completed Condition: Pain

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

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

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Status: Recruiting Condition: Post Operative Dental Pain

Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Status: Terminated Condition: Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain

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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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
6,475,795 Use of hyaluronan in gene therapy<disabled in preview>
5,929,048 Treatment of conditions and disease<disabled in preview>
5,817,642 Clearing of atherosclerosis<disabled in preview>
5,914,314 Use of a form of hyaluronic acid and a medicinal agent for reducing rejection of organs transplantation in mammals<disabled in preview>
5,614,506 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
Japan4005628Nov 07, 2007
Australia739601Oct 18, 2001
Austria200736May 15, 2001
Germany69034018Jul 24, 2003
Denmark0626863Jul 30, 2001
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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.

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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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