SOLARAZE Drug Patent Profile

Which patents cover Solaraze, and when can generic versions of Solaraze launch?

Solaraze is a drug marketed by Fougera and is included in one NDA.

The generic ingredient in SOLARAZE is diclofenac sodium. There is one drug master file entry for this compound. One hundred and twenty-four 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:	6,910
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
Encube Ethicals Pvt. Ltd.	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	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	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,639,738
Fougera	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,914,322
Fougera	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,852,002
Fougera	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,929,048
Fougera	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,792,753
Fougera	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,985,850

International Patents for SOLARAZE

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	175	Combination and formulations and the administration thereof to a mammal for the treatment of conditions and disease.
African Regional IP Organization (ARIPO)	448	Use of hyaluronic acid and forms to prevent arterial restenosis.
African Regional IP Organization (ARIPO)	475	Pharmaceutical formulations containing hyaluronic acid.
African Regional IP Organization (ARIPO)	476	Treatment of disease employing hyaluronic acid and nsaids.
African Regional IP Organization (ARIPO)	618	Modulation of cellular activity by administering a form of hyaluronic acid.
African Regional IP Organization (ARIPO)	9000206

SOLARAZE (diclofenac epolamine topical) market dynamics and financial trajectory: exclusivity, competitive set, and revenue exposure

Last updated: June 13, 2026

Market dynamics for SOLARAZE: how is diclofenac epolamine performing commercially?

SOLARAZE is a branded topical nonsteroidal anti-inflammatory drug (NSAID) with the active ingredient diclofenac epolamine, marketed for pain associated with minor strains, sprains, and contusions. In the U.S., the commercial trajectory for branded topical NSAIDs is shaped by (1) loss of primary patent exclusivity, (2) penetration by authorized generics and standard generics once Orange Book barriers erode, (3) payer and pharmacy benefit manager (PBM) formulary placement, and (4) retail vs. mail volume mix.

What typically drives price and volume

• Formulary access: Topical NSAIDs face tier pressure as generics expand. Brand revenue usually declines after generic substitution becomes routine.
• Channel mix: Retail pharmacy typically captures initial brand demand; mail and long-tail dispensing support once generics enter.
• SKU architecture: Diclofenac epolamine products compete on tube size, carton count, and pharmacy shelf economics more than on mechanism.
• Medical-claim substitution: Once equivalent coverage is available, prescribers shift quickly to lower net-price options.

What patents protect SOLARAZE and how does the patent estate affect revenue?

Executive answer: The revenue runway for SOLARAZE depends on whether any Orange Book-listed patents remain enforceable against diclofenac epolamine topical products, including formulation, method-of-use, and packaging patents. After barrier clearance, generic entry typically compresses brand net pricing.

Because this analysis requires SOLARAZE-specific Orange Book and patent identifiers (publication numbers, expiration dates, and listed patent claims) to map “when revenue is at risk,” and that data is not provided in the prompt, no accurate patent estate can be stated here without risking factual error.

Which patent types usually matter for topical diclofenac brands?

• Formulation patents: concentrate on drug loading, carrier system, penetration enhancers, and stability.
• Method-of-use patents: target specific dosing regimens or indications.
• Packaging or manufacturing patents: cover container systems or process controls.

When does SOLARAZE lose exclusivity? What are the key expiration and exclusivity dates?

Executive answer: Exclusivity and patent expiration dates are the gating items for forecastable revenue erosion. This requires Orange Book listing data for SOLARAZE, including the earliest expiration among relevant patents and any pediatric exclusivity or marketing exclusivity. That dataset is not included in the prompt, so a precise timeline cannot be produced.

What “loss of exclusivity” means in practice for topical NSAIDs

• Orange Book barrier removal: drives generic filing opportunities (ANDA Paragraph IV for statutory exclusivity challenges).
• Settlement or noninfringement outcomes: determine whether generic launch is delayed beyond the earliest patent expiration.
• Brand erosion curve: typically steep in the first 6 to 24 months after meaningful generic availability.

What is the Orange Book status of SOLARAZE?

Executive answer: Orange Book status is determined by patent listings tied to the approved NDA and each listed dosage form and strength. Without SOLARAZE Orange Book entry data, the number of patents, claim descriptions, and each patent’s status cannot be listed accurately.

How many patents cover diclofenac epolamine topical products?

An accurate count must come from the Orange Book for SOLARAZE specifically. A generic statement like “x patents” would be error-prone and is not included.

What generic entry risks exist for SOLARAZE?

Executive answer: Generic entry risk is high once Orange Book barriers are cleared because topical diclofenac mechanisms are not protected at the class level in a way that blocks substitution. The actual risk timing depends on (1) whether any listed patents are still enforceable, (2) whether any ANDA challenges are pending, and (3) whether settlements delay launches.

How Paragraph IV challenges typically change launch timing

• If a Paragraph IV is successful: generic can launch at risk, then potentially share damages exposure.
• If a settlement is reached: launch is often delayed to a date negotiated between brand and first filers.

What patent litigation affects SOLARAZE?

Executive answer: Patent litigation affects launch timing through injunctions, stay motions, and settlements. A correct litigation timeline requires case captions, dockets, and decision dates tied to SOLARAZE’s Orange Book patents. None are included in the prompt, so litigation events cannot be stated reliably.

How does SOLARAZE compare with other topical diclofenac brands and generics?

Executive answer: SOLARAZE competes in the topical diclofenac NSAID landscape where multiple marketed brands and generics coexist, driving share shift toward lowest net cost and preferred formulary status. Competitive intensity is usually sustained because topical NSAID dosing and patient acceptance are broadly similar across products.

Typical competitive set (by drug class)

• Other branded topical diclofenac products
• Authorized generics and standard generics of diclofenac epolamine
• Other topical NSAIDs (e.g., diclofenac sodium formulations and different NSAID actives)

A product-by-product share and pricing comparison requires current IMS/industry data or company disclosures that are not provided in the prompt, so a numeric market share or pricing table cannot be constructed.

What formulations are protected by SOLARAZE patents?

Executive answer: Formulation protection is usually present for topical NSAIDs via carrier system composition, penetration enhancer concentration, and stability targets. The exact formulation-claim scope for SOLARAZE depends on listed formulation patents tied to the NDA and dosage forms.

Without SOLARAZE’s Orange Book formulation patent numbers and claims, any mapping of protected formulations would risk inaccuracy.

What licensing deals exist for SOLARAZE generics?

Executive answer: Licensing and settlement agreements can govern generic launch dates and market share distribution among authorized entrants. Identifying those agreements requires known settlement press releases, court dockets, and the ANDA filer landscape for SOLARAZE. None are provided.

FDA regulatory status for SOLARAZE: what pathway and what approvals drive supply and launch?

Executive answer: SOLARAZE is already approved and marketed; the current regulatory status relevant to financial trajectory is whether subsequent ANDAs for generic versions are approved and whether the listed patents block approval or launch. This also depends on latest FDA approvals and patent certification types (Paragraph I, II, III, IV). Those items require Orange Book and FDA approval listings.

Commercial trajectory for SOLARAZE: how do revenues evolve as competition increases?

Executive answer: Branded topical NSAID revenue usually follows a predictable post-exclusivity pattern:

1. Pre-generic: brand holds share with pricing power on non-preferred tiers and high-acceptance prescribers.
2. First meaningful generic: net pricing declines as PBMs tighten formularies and pharmacists substitute.
3. Broad generic coverage: brand volume erosion accelerates; remaining premium is supported only where payer policies treat specific products differently or where patient preference persists.
4. Long-tail stabilization: brand persists at lower share for chronic or entrenched use patterns, but profitability depends on cost structure and pricing discipline.

A precise financial trajectory (revenue numbers, growth rate, time-to-decline) requires SOLARAZE-specific financial disclosures, market research, or sales estimates. The prompt does not provide these data.

Revenue exposure map that drives internal forecasting

Even without numbers, companies typically model exposure along these axes:

• Share erosion rate: expected speed of substitution after generic launches
• Net price decline: PBM-driven rebates and contract price resets
• Gross-to-net: rebate concentration changes post-generic
• Inventory and supply: whether the brand maintains competitive fill rates during early generic launches
• Channel shift: retail to mail and wholesaler ordering patterns

Geographic coverage: where is SOLARAZE most exposed to generic substitution?

Executive answer: Generic risk is jurisdiction-specific. In the U.S., Orange Book and ANDA systems determine launch timing. Outside the U.S., coverage is driven by local patent enforcement and marketing authorization exclusivity, which requires jurisdictional filings. The prompt provides no geographic authorization or patent enforcement data, so cross-territory conclusions cannot be stated.

How strong is the patent estate for SOLARAZE?

Executive answer: Patent estate strength cannot be scored without enumerating remaining Orange Book patents, their expiration dates, claim breadth, and litigation posture. Those inputs are not provided.

Key takeaways

• SOLARAZE’s financial trajectory in the U.S. is driven by Orange Book barriers, generic substitution dynamics, and formulary access.
• Precise revenue risk timing requires SOLARAZE-specific Orange Book listings, patent expiration dates, and any Paragraph IV or settlement outcomes.
• Competitive intensity in topical NSAIDs typically compresses net price and share after barrier clearance, producing a steep erosion period followed by stabilization at lower profitability unless supply and contracting remain advantageous.

FAQs

1. How fast do topical diclofenac brands lose market share after generic entry?
2. Do settlements for diclofenac epolamine topical products delay generic launch beyond patent expiration?
3. What PBM formulary levers most affect SOLARAZE net pricing versus generics?
4. How do manufacturing and formulation patents change ANDA design-around risk for diclofenac epolamine?
5. Which Orange Book patent certifications (I, II, III, IV) most influence SOLARAZE launch timing?

References

1. (No sources cited because SOLARAZE-specific Orange Book, patent, litigation, and financial data were not provided in the prompt.)