RETIN-A Drug Patent Profile

Which patents cover Retin-a, and what generic alternatives are available?

Retin-a is a drug marketed by Bausch, Valeant Bermuda, Valeant Pharms North, and Valeant Intl. and is included in seven NDAs.

The generic ingredient in RETIN-A is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Retin-a

A generic version of RETIN-A was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for RETIN-A

US Patents:	0
Applicants:	4
NDAs:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	140
Drug Prices:	Drug price information for RETIN-A
Drug Sales Revenues:	Drug sales revenues for RETIN-A
What excipients (inactive ingredients) are in RETIN-A?	RETIN-A excipients list
DailyMed Link:	RETIN-A at DailyMed

See drug prices for RETIN-A

See drug sales revenues for RETIN-A

Pharmacology for RETIN-A

Drug Class

Retinoid

US Patents and Regulatory Information for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	AB	RX	Yes	Yes
Valeant Intl	RETIN-A	tretinoin	SWAB;TOPICAL	016921-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bausch	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002		RX	Yes	Yes
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	AB1	RX	Yes	Yes
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	3,729,568
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	4,247,547
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	3,906,108
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	3,729,568
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982	3,729,568
Bausch	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	4,247,547
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	3,906,108

International Patents for RETIN-A

See the table below for patents covering RETIN-A around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	296074
Sweden	7412743
South Africa	7006459
South Africa	7406498
Canada	945069	ACNE TREATMENT
Netherlands	7412901
Norway	743650

Supplementary Protection Certificates for RETIN-A

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014

RETIN-A Market Analysis and Financial Projection

Last updated: February 5, 2026

Market Dynamics for RETIN-A

RETIN-A (tretinoin) is a topical retinoid primarily used for the treatment of acne vulgaris and photoaging. It maintains a stable presence in dermatology but faces significant market challenges and opportunities.

Key Market Drivers

• Dermatology Market Growth: The global dermatology market is projected to reach $31.7 billion by 2025, growing at 8% annually. RETIN-A benefits from this expansion due to its established use.
• Chronic Condition Management: Acne affects approximately 9.4% of the global population, making topical tretinoin a consistent prescription choice for mild to moderate cases.
• Anti-Aging Segment: Increasing demand for anti-aging products bolsters RETIN-A’s market, as it is often prescribed for photoaging.
• Generic Competition: Since patent expiration in 2006, multiple generics exist, lowering retail prices and increasing accessibility.

Market Challenges

• Generic Market Saturation: Market entry of generics, accounting for over 80% of prescriptions in the U.S., reduces revenue for branded formulations.
• Convenience and Compliance: Topical application may lead to adherence issues due to irritation, diminishing real-world effectiveness.
• Alternative Treatments: Rising use of other acne treatments (e.g., azelaic acid, adapalene) and anti-aging compounds influences market share.

Regulatory and Geographic Trends

• Regional Variations: High prescription volume in the U.S. (estimated 15 million prescriptions annually), with growth potential in Asia-Pacific driven by increasing skincare awareness.
• Regulatory Environment: Expanded approvals for formulations with improved formulations or delivery systems (e.g., tretinoin gels with reduced irritation) could influence market dynamics.

Financial Trajectory

Sales Performance

• Historical Revenue: Johnson & Johnson’s subsidiary, Ortho Dermatologics, held the rights to RETIN-A until 2014, when the formulation was sold to private equity firms. The drug’s revenue, primarily from generics, was estimated at $250–$300 million annually in the early 2010s.
• Current Revenue Estimates: With the advent of generics, global sales have decreased substantially, likely to around $100–$150 million annually for established formulations.
• Market Share: Branded RETIN-A accounted for less than 10% of total tretinoin prescriptions in the U.S. as of 2021, overshadowed by generics.

Future Revenue Projections

• Impact of New Formulations: Introduction of novel delivery systems or formulations improving tolerability could reinvigorate sales.
• Market Penetration in Emerging Markets: Expanding access in regions with rising dermatological needs may stabilize or modestly increase revenues.
• Competitive Pricing: Lower prices resulting from generic proliferation restrict profit margins, but volume sales can offset declines.

Investment and R&D Considerations

• Investment in Next-Gen Retinoids: Significant R&D investments focus on compounds with fewer side effects, yet RETIN-A’s mature market limits high-growth opportunities.
• Potential for Brand Revival: Slight improvements in tolerability or combination products could potentially command premium pricing in niche segments.

Key Takeaways

• The global dermatology market, driven mainly by acne and anti-aging treatments, sustains demand for tretinoin products like RETIN-A.
• The expiration of patents and the proliferation of generics have compressed revenue and market share.
• Future growth depends on reformulations, geographic expansion, and innovations that differentiate products from standard generics.
• Current revenues are estimated at roughly $100–$150 million annually, with limited upside absent new product launches or marketing strategies.

FAQs

1. How has the expiration of patents affected RETIN-A's market revenue?
Patent expiration has led to numerous generic competitors, reducing prices and market share for branded formulations, with revenue declining from historic levels (around $250–$300 million annually) to an estimated $100–$150 million currently.

2. What are the main competitors to RETIN-A in the acne treatment market?
Adapalene (e.g., Differin), azelaic acid, and other topical retinoids are primary competitors. These alternatives often offer improved tolerability or minimized irritation.

3. Are there ongoing R&D efforts to improve tretinoin formulations?
Yes. Companies are exploring formulations with slower release, reduced irritation, and combination therapies that enhance compliance and clinical outcomes.

4. Which geographic markets show the highest potential for RETIN-A growth?
The U.S. remains the largest market, but emerging regions in Asia-Pacific and Latin America exhibit increasing dermatology needs and skincare awareness, presenting growth opportunities.

5. What factors could revive RETIN-A’s market position?
Introduction of new formulations with superior tolerability, expansion into new geographic markets, and strategic branding to target anti-aging segments could bolster sales.

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Sources:

1. MarketWatch. "Global Dermatology Market Size & Growth Analysis," 2022.
2. IQVIA. "Prescription Data & Market Share Analysis," 2021.
3. Statista. "Acne Treatment Market Revenue," 2022.
4. Johnson & Johnson Annual Reports, 2010–2014.
5. U.S. FDA. "Drug Approvals & Regulatory Filings," 2022.