SOLARAZE Drug Patent Profile

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-seven 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.

Summary for SOLARAZE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	11
Patent Applications:	3,734
What excipients (inactive ingredients) are in SOLARAZE?	SOLARAZE excipients list
DailyMed Link:	SOLARAZE at DailyMed

See drug sales revenues 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
Novum Pharmaceutical Research Services	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

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

Expired US Patents for SOLARAZE

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

International Patents for SOLARAZE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9530423
Hungary	227067	USE OF HYALURONIC ACID FOR PREPARING PHARMACEUTICAL COMPOSITIONS TO PREVENT ARTERIAL RESTENOSIS
Norway	309457
Austria	244020

SOLARAZE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Solaraze

Overview of Solaraze

Solaraze, also known as diclofenac sodium gel, is a topical nonsteroidal anti-inflammatory drug (NSAID) used primarily for the treatment of actinic keratosis (AK), a precursor to skin cancer. Here’s a detailed look at the market dynamics and financial trajectory of Solaraze.

Market Size and Growth

The U.S. actinic keratosis treatment market, in which Solaraze is a key player, has been experiencing steady growth. As of 2022, the market size was valued at USD 2.32 billion and is expected to expand at a compound annual growth rate (CAGR) of 3.03% from 2023 to 2030, reaching USD 2.94 billion by 2030[1][4].

Segment Performance

Topical/Drugs Segment

Solaraze falls under the topical/drugs segment, which is dominated by nucleoside metabolic inhibitors. However, the nonsteroidal anti-inflammatory drugs (NSAIDs) category, where Solaraze is classified, also holds a significant market share. The demand for topical formulations, such as Solaraze, is driven by their effectiveness in treating the initial stages of actinic keratosis[1][4].

Product Outlook

Solaraze, specifically, is one of the key products in the NSAIDs category. Along with other products like Pennsaid and Voltaren, Solaraze contributes to the revenue generated by this segment. The product's performance is influenced by factors such as its efficacy, patient compliance, and the rising awareness about AK diagnosis and treatment[1].

Financial Performance

Revenue Contribution

Solaraze is part of the broader portfolio of pharmaceutical companies such as Novartis and other manufacturers. While specific financial data for Solaraze alone is not readily available, the overall revenue from the NSAIDs segment within the AK treatment market is substantial. For instance, the total revenue from the topical/drugs segment, which includes Solaraze, is projected to continue growing due to the strong commercial performance of these products[1][4].

Competitive Landscape

The market for AK treatments is competitive, with several key players including Bausch Health Companies, Inc., LEO Pharma A/S, Almirall, S.A, Biofrontera AG, and Novartis AG. Solaraze competes with other topical treatments such as imiquimod (Aldara, Zyclara) and fluorouracil (Carac, Fluoroplex). The competitive landscape is driven by factors such as product efficacy, side effect profiles, and marketing strategies[4].

Growth Drivers

Rising Awareness and Diagnosis

The growth of the AK treatment market, including Solaraze, is significantly driven by the increasing awareness and diagnosis of actinic keratosis. As more patients are diagnosed and treated, the demand for effective topical treatments like Solaraze increases[1][4].

Clinical Studies and Innovations

Ongoing clinical studies and innovations in treatment modalities also contribute to the growth of the market. For example, the initiation of phase-3 clinical studies to evaluate the safety and efficacy of other treatments can indirectly benefit Solaraze by highlighting the importance of topical treatments in AK management[4].

Challenges and Opportunities

Photodynamic Therapy (PDT)

While Solaraze remains a popular treatment, the photodynamic therapy segment is projected to register the fastest growth rate over the forecast period. This is due to the high site specificity, lower incidence of adverse effects, and high adoption rate for long-term treatments of PDT. However, this also presents an opportunity for Solaraze to be used in combination with PDT or as an alternative treatment option[4].

Regulatory and Market Trends

Changes in regulatory environments and market trends can impact the financial trajectory of Solaraze. For instance, shifts in healthcare policies or reimbursement rates can affect the market share and revenue of the product[1].

Key Takeaways

• Market Growth: The U.S. actinic keratosis treatment market is expected to grow at a CAGR of 3.03% from 2023 to 2030.
• Segment Performance: Solaraze is part of the NSAIDs segment, which holds a significant market share within the topical/drugs segment.
• Financial Performance: While specific revenue data for Solaraze is not available, the overall revenue from the NSAIDs segment is substantial and growing.
• Competitive Landscape: Solaraze competes with other topical treatments, and the market is driven by product efficacy, side effect profiles, and marketing strategies.
• Growth Drivers: Rising awareness and diagnosis of AK, along with ongoing clinical studies, drive the growth of the market.

FAQs

What is Solaraze used for?

Solaraze, or diclofenac sodium gel, is used for the treatment of actinic keratosis (AK), a precursor to skin cancer.

How does the market for AK treatments grow?

The market for AK treatments grows due to increasing awareness and diagnosis of AK, as well as the strong commercial performance of topical formulations like Solaraze.

What segment does Solaraze belong to?

Solaraze belongs to the nonsteroidal anti-inflammatory drugs (NSAIDs) segment within the topical/drugs category.

Who are the key competitors in the AK treatment market?

Key competitors include Bausch Health Companies, Inc., LEO Pharma A/S, Almirall, S.A, Biofrontera AG, and Novartis AG.

What are the growth drivers for Solaraze?

Growth drivers include rising awareness and diagnosis of AK, ongoing clinical studies, and the efficacy of Solaraze as a topical treatment.

Sources

1. Grand View Research: U.S. Actinic Keratosis Treatment Market Size Report, 2030.
2. Jazz Pharmaceuticals: Full Year and Fourth Quarter 2023 Financial Results.
3. PharmaLive: AstraZeneca 2023: Pushed by science.
4. NovaOne Advisor: U.S. Actinic Keratosis Treatment Market Size, Share, Trends.