SOLAGE Drug Patent Profile

Which patents cover Solage, and what generic alternatives are available?

Solage is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in SOLAGE is mequinol; tretinoin. There is one drug master file entry for this compound. Additional details are available on the mequinol; tretinoin profile page.

Summary for SOLAGE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	140
Patent Applications:	3
DailyMed Link:	SOLAGE at DailyMed

US Patents and Regulatory Information for SOLAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999		DISCN	No	No

Expired US Patents for SOLAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999

International Patents for SOLAGE

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

Country	Patent Number	Title	Estimated Expiration
Austria	104544
Brazil	1100177
Canada	2022917	COMPOSE SYNERGIQUE POUR LA DEPIGMENTATION DE LA PEAU (SYNERGISTIC SKIN DEPIGMENTATION COMPOSITION)
Germany	69008293
Denmark	0421110
European Patent Office	0421110	Composition synergique de dépigmentation de la peau. (Synergistic skin depigmentation composition.)

SOLAGE market dynamics and financial trajectory: revenue drivers, pricing pressure, exclusivity cliffs, and expected competitive churn

Last updated: July 30, 2026

Solage is a brand name that is not uniquely identifiable from the available information set as a single, FDA-approved pharmaceutical product with a mapped active ingredient, dosage form, manufacturer, and Orange Book exclusivity/patent record. Without an unambiguous drug identity, a complete and accurate market dynamics and financial trajectory cannot be produced.

What is Solage’s active ingredient and who markets it?

Direct answer: The active ingredient, dosage form, NDA/BLA status, and marketing company for “SOLAGE” cannot be confirmed from the provided input, so its revenue drivers and financial trajectory cannot be mapped to specific filings, product labels, and payer dynamics.

What FDA approval and regulatory pathway does Solage use?

Direct answer: The FDA approval record (NDA number, approval date, pathway such as 505(b)(2), 505(b)(1), or ANDA route of entry for generics) is not identifiable from the provided input.

What is Solage’s formulary positioning and payer mix?

Direct answer: Payer mix, restricted formulary status, prior authorization triggers, and copay card presence are not identifiable from the provided input.

How do Solage’s sales and revenue trend over time?

Direct answer: Historical sales, net revenue, growth rate, and quarter-by-quarter trajectory cannot be determined without knowing the specific product identity (active ingredient, strength, and manufacturer).

Which filings and disclosures would show Solage revenue?

Direct answer: Revenue reporting sources like company segment notes, investor decks, and label-specific quarterly sales tables are not identifiable for an unconfirmed product.

What are the key KPIs for Solage’s financial trajectory?

Direct answer: Without product identification, KPIs such as prescriptions, script growth, average net price (ANP), gross-to-net rate, rebates, and buy-and-bill dynamics cannot be computed or attributed.

When does Solage lose exclusivity and what does that mean for earnings?

Direct answer: A valid exclusivity timeline requires an Orange Book patent list and regulatory exclusivity link for the exact Solage product.

When does Solage lose patent protection?

Direct answer: Patent expiration and exclusivity dates cannot be produced without mapping Solage to a known NDA/BLA and listed patents.

When does Solage lose FDA exclusivity (NCE, 3-year, 7-year, pediatric extensions)?

Direct answer: FDA exclusivity periods cannot be determined without product identification.

How many patents protect Solage and what is the strength of the estate?

Direct answer: A count of protecting patents, claim scope, and remaining term depends on the Orange Book patent listing for the specific drug.

What patent types usually matter for a brand like Solage?

Direct answer: Without identification, the portfolio cannot be categorized into compositions, formulations, dosing regimens, methods of use, manufacturing processes, or device-adjacent IP.

How many Paragraph IV ANDA challenges target Solage?

Direct answer: Paragraph IV activity cannot be enumerated without confirming the ANDA-targeted drug.

What generic and biosimilar entry risks exist for Solage?

Direct answer: Generic entry risks depend on the active ingredient and exclusivity status.

What launch scenarios could compress Solage net price?

Direct answer: Generic entry timing, first-wave share capture, and price erosion rates cannot be modeled without the product’s exclusivity end date and competitive set.

Are there authorized generics or settlement barriers affecting Solage?

Direct answer: Settlement agreements and authorized generic arrangements are not identifiable without product identity.

What Orange Book status does Solage have and what is the filing history?

Direct answer: Orange Book status cannot be stated for an unconfirmed Solage product.

Is Solage listed as an NDA or BLA product in the Orange Book?

Direct answer: Cannot be confirmed from the provided input.

Are there REMS, pediatric exclusivity, or 505(b)(2) bridging elements impacting entry?

Direct answer: Not identifiable from the provided input.

Which companies compete with Solage and how does Solage compare commercially?

Direct answer: Competitive set cannot be established without the active ingredient class and mechanism.

Which alternatives are closest in class and what is the switching barrier?

Direct answer: Not identifiable without product identification.

What does payer prefer: branded Solage vs generics or class alternatives?

Direct answer: Not identifiable without product identification.

What formulation or method-of-use patents drive Solage’s IP and licensing deals?

Direct answer: The formulation and method-of-use patent landscape cannot be enumerated for an unconfirmed product.

What dosage strengths and delivery systems are protected for Solage?

Direct answer: Not identifiable from the provided input.

What licensing deals have been reported for Solage’s IP estate?

Direct answer: Not identifiable without identifying the correct product and patent holders.

What Solage litigation affects timelines for generics or biosimilars?

Direct answer: Patent litigation events (infringement actions, PTAB challenges, ANDA litigation) require the correct drug identity.

Which parties have been litigating against Solage generics?

Direct answer: Not identifiable.

What settlements or court rulings set entry dates for Solage?

Direct answer: Not identifiable.

Commercial forecast: how will Solage earnings behave under patent expiry pressure?

Direct answer: No forecast can be produced without a verified Solage product mapping to exclusivity and patent expiry.

Base, downside, and upside scenarios for Solage

Direct answer: Not computable without the product’s exclusivity timeline and competitive entry assumptions.

Revenue sensitivity to price erosion and utilization changes

Direct answer: Not computable without net price trajectory, rebate rate profile, and utilization data.

Key Takeaways

• “SOLAGE” cannot be tied to a single, specific FDA-approved pharmaceutical product from the provided input, so exclusivity, patent estate, and market drivers cannot be mapped.
• A complete market dynamics and financial trajectory requires unambiguous product identity (active ingredient, NDA/BLA, dosage form, and manufacturer) to connect sales disclosures, Orange Book status, and competitive timelines.

FAQs

1. What does “Solage” refer to in FDA and Orange Book records?
2. Is Solage protected by composition-of-matter patents, formulation patents, or method-of-use claims?
3. What exclusivity end date drives generic entry for Solage?
4. Are there Paragraph IV ANDA filings challenging Solage’s patents?
5. How fast do prices typically fall after generic entry for Solage’s drug class?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).