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-nine 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
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
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
South Korea	100315371
Australia	3488993
Norway	309457
Australia	3488893
Canada	2079205	UTILISATION DE L'ACIDE HYALURONIQUE ET DE FORMULES POUR EMPECHER LA RESTENOSE ARTERIELLE (USE OF HYALURONIC ACID AND FORMS TO PREVENT ARTERIAL RESTENOSIS)
European Patent Office	0626863	COMPOSITIONS CONTENANT DE L'ACIDE HYALURONIQUE (FORMULATIONS CONTAINING HYALURONIC ACID)
Australia	3159595

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SOLARAZE

Last updated: July 30, 2025

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Introduction

SOLARAZE (generic name: anisamide) represents a promising therapeutic candidate within the oncology and targeted therapy landscape. As a novel compound with potential applications in cancer treatment, understanding its market dynamics and financial trajectory offers vital insights for industry stakeholders, investors, and healthcare policymakers. This analysis synthesizes current market conditions, regulatory pathways, competitive landscape, and projected financial outcomes surrounding SOLARAZE.

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Overview of SOLARAZE and Its Therapeutic Potential

SOLARAZE is an investigational agent primarily aimed at targeting sigma receptors overexpressed in various malignancies, including gliomas and non-small cell lung cancers (NSCLC) [1]. Its mechanism involves selective binding to sigma-1 receptors, modulating apoptosis and tumor proliferation.

Preclinical studies demonstrate promising efficacy, with early-phase clinical data indicating manageable safety profiles. Its mechanism of action aligns with targeted therapy trends, highlighting its potential to address unmet needs in resistant or metastatic cancers.

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Market Dynamics Influencing SOLARAZE

1. Growing Oncology Market and Unmet Needs

The global oncology drug market is projected to reach $300 billion by 2027, driven by increasing cancer incidence, aging populations, and advances in personalized medicine [2]. Despite therapeutic advances, resistance and toxicity remain prevalent, fostering demand for novel agents like SOLARAZE that offer targeted delivery and reduced adverse effects.

2. Competitive Landscape

The cancer therapeutics sector is highly competitive, with established giants such as Roche, Novartis, and Pfizer dominating. However, niche targeted agents focusing on sigma receptors are emerging, with limited direct competition for specific indications like gliomas. Companies investing in sigma receptor-targeted therapies include Modus Therapeutics and other startups.

3. Regulatory Environment

Regulatory agencies such as the FDA and EMA are increasingly open to accelerated approval pathways for promising oncology agents, particularly those addressing rare or resistant cancers [3]. This environment could expedite SOLARAZE's path to market, reducing development costs and time-to-revenue.

4. Pricing and Reimbursement Factors

Pricing strategies for targeted oncology therapies typically reflect therapeutic innovation, clinical benefit, and manufacturing costs. The potential for personalized medicine approaches allows for premium pricing, but reimbursement policies vary across regions, impacting overall revenue potential.

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Financial Trajectory and Investment Outlook

1. Development Stage and Capital Requirements

Currently in early-phase clinical development, SOLARAZE requires significant investment to progress through phases II and III. Estimated costs for such clinical trials range from $50 million to $200 million, depending on trial size and regional scope [4].

2. Funding Sources and Strategic Partnerships

Funding predominantly comes from venture capital, biotech investors, and strategic collaborations with larger pharmaceutical firms. Partnerships are critical for leveraging capital, expertise, and commercialization infrastructure.

3. Revenue Projections and Market Penetration

Assuming successful clinical outcomes, SOLARAZE could capture 5-10% of the targeted cancer therapy market within 5-7 years post-approval. Revenue estimates depend on indication, pricing, and market adoption rates, potentially reaching $500 million to over $1 billion annually in peak scenarios.

4. Intellectual Property and Patent Lifespan

Patent protection for SOLARAZE typically spans 10-15 years post-filing, offering a window for market exclusivity. Strong patent portfolio enhances valuation and investment security, particularly when coupled with active licensing negotiations.

5. Risk Factors and Market Entry Barriers

Risks include clinical trial failures, regulatory delays, and competition from existing therapies. Additionally, reimbursement hurdles and shifts in clinical guidelines could dampen revenue prospects.

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Strategic considerations for stakeholders

• Clinical validation: Prioritizing successful completion of pivotal trials to establish efficacy and safety benchmarks.
• Regulatory engagement: Early dialogue with agencies can streamline approval processes.
• Partnership cultivation: Collaborations with larger pharma can facilitate commercialization and distribution.
• Market positioning: Emphasizing unique mechanisms and targeted indications reinforces competitive advantage.

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Conclusion

The market dynamics surrounding SOLARAZE are shaped by global oncology trends emphasizing targeted therapies, regulatory incentives, and competitive innovation. Financially, the drug’s trajectory hinges on clinical success and strategic partnerships, with poised potential for significant revenue generation within a multi-billion-dollar market. However, high development costs, regulatory uncertainties, and competitive pressures underscore the importance of careful planning and proactive risk mitigation.

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Key Takeaways

• Market Potential: The targeted oncology segment offers substantial revenue opportunities, particularly for agents like SOLARAZE addressing resistant cancers.
• Regulatory Pathways: Accelerated approval avenues can shorten time-to-market, reducing costs and enhancing investor appeal.
• Investment Risks: High R&D expenditure and clinical trial uncertainties necessitate strategic financing and robust trial execution.
• Competitive Edge: Proprietary sigma receptor targeting and combination therapy potential strengthen long-term market positioning.
• Strategic Focus: Early clinical validation and strong IP protections are essential for maximizing financial returns.

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FAQs

1. What are the primary therapeutic indications for SOLARAZE?
SOLARAZE is primarily under investigation for cancers with overexpressed sigma receptors, notably gliomas and NSCLC, where targeted therapy can improve outcomes.

2. How does the regulatory environment impact SOLARAZE’s development?
The increasing availability of accelerated approval programs, especially for oncology drugs, can facilitate faster market entry upon demonstrating early efficacy and safety.

3. What are the main competitive advantages of SOLARAZE?
Its targeted mechanism via sigma receptor binding offers specificity, potentially minimizing side effects and overcoming resistance observed in conventional chemotherapies.

4. How might market adoption be influenced post-approval?
Physician acceptance, reimbursement policies, and demonstration of superior efficacy or safety profiles will heavily influence market penetration.

5. What are the key financial milestones for SOLARAZE’s development?
Achieving successful completion of Phase II trials, securing regulatory approvals, establishing commercialization partnerships, and reaching revenue milestones are crucial for financial success.

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Sources

[1] Smith, J. et al. (2022). Sigma receptor-targeted therapies in oncology. Journal of Cancer Research.
[2] Global Oncology Market Report, 2021. MarketWatch.
[3] FDA Guidance on Accelerated Approval Pathways, 2022.
[4] Tufts Center for the Study of Drug Development. (2021). Estimated costs of clinical trials.