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-seven 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

Expired US Patents for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988
Bausch	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982

International Patents for RETIN-A

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1325732
India	140593	PROCESS FOR PREPARING STABILIZED TRETIN-OIN CREAM EMULSION FOR TOPICAL APPLICATION
South Africa	7406498
Germany	2046119
Norway	137627
Australia	7408474

Supplementary Protection Certificates for RETIN-A

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
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	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014

Market Dynamics and Financial Trajectory for RETIN-A

Last updated: July 29, 2025

Introduction

RETIN-A, known generically as tretinoin, is a topical medication primarily used for acne vulgaris and keratinization disorders, with additional applications in anti-aging regimens. As a pioneering retinoid introduced in the 1970s, RETIN-A has cemented its position within dermatological treatments, witnessing evolving market dynamics driven by innovation, regulatory landscapes, and consumer preferences. This article examines the current market situation, competitive environment, regulatory influences, and the financial outlook for RETIN-A, providing business professionals with a strategic understanding of this legacy drug’s trajectory.

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Market Overview and Therapeutic Demand

RETIN-A’s longstanding efficacy in treating acne and photoaging has ensured consistent demand. Despite the emergence of newer retinoids and alternative skincare formulations, tretinoin remains a first-line therapy due to its proven safety profile and FDA approval status. The global market for topical retinoids is projected to grow at a compound annual growth rate (CAGR) of approximately 6.2% from 2022 to 2030, driven by increasing consumer awareness of skincare, aging populations, and unmet needs in dermatological therapeutics [1].

In mature markets such as North America and Europe, prescriptions for tretinoin sustain steady levels, supplemented by over-the-counter (OTC) availability of lower-strength formulations. The Asia-Pacific region exhibits significant growth potential, fueled by rising skincare consciousness and expanding dermatology infrastructure.

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Competitive Landscape

The market for tretinoin is characterized by a combination of branded and generic formulations. Johnson & Johnson and Bayer historically dominated, producing prescription-strength formulations. Recently, the market has seen a surge in generic manufacturers and private-label products, intensifying price competition.

Innovations in formulation science, including microencapsulation and combination therapies, aim to improve tolerability, efficacy, or convenience, challenging the traditional RETIN-A products. Additionally, the entry of novel topical retinoids such as adapalene (Differin) offers alternative treatment options, albeit usually with different safety profiles and indications.

Notably, the availability of OTC retinoids in many regions diminishes the exclusive market share of prescription tretinoin, especially among consumers seeking self-medication options. The proliferation of OTC products also pressures pharmaceutical companies to innovate and differentiate their formulations.

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Regulatory and Intellectual Property Considerations

RETIN-A’s patent landscape is complex. The original patents expired in most regions by early 2010s, ushering in widespread generic competition. However, some formulations or delivery mechanisms retain exclusivity, providing niche market advantages.

Regulatory bodies like the FDA maintain rigorous standards for topical drugs, impacting formulation modifications and combination therapies. Changes in classification, such as reclassification from prescription to OTC in certain geographies, significantly influence market access and revenue streams.

Given the patent expirations and increased generic presence, brand loyalty becomes critical in maintaining market share. Companies investing in formulation patents, such as combination creams with antibiotics or anti-inflammatory agents, attempt to extend product lifecycle.

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Pricing and Reimbursement Dynamics

Pricing strategies are influenced by generic competition, manufacturing costs, and reimbursement policies. In markets with high insurance penetration, prescription coverage buffers price erosion; conversely, in OTC settings, consumer price sensitivity heightens.

Reimbursement policies favor cost-effective generics, pressuring branded formulations to justify premium pricing through added value, such as improved tolerability or convenience. The proliferating OTC options also cede pricing power, demanding innovative new formulations to retain consumer interest.

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Emerging Trends Shaping the Financial Trajectory

1. Formulation Innovation:
   Companies are exploring nanoemulsions and liposomal delivery of tretinoin to improve skin penetration and minimize irritation, which could command premium pricing and capture niche segments.

2. Combination Products:
   Combining tretinoin with other skincare actives like hyaluronic acid or antioxidants offers enhanced efficacy and reduced side effects, appealing to a broader consumer base and supporting higher margins.

3. Digital Marketing and Direct-to-Consumer Channels:
   The rise of digital platforms and influencer marketing accelerates consumer engagement, especially among millennials and Gen Z demographics, pushing product demand.

4. Personalized Medicine:
   Advances in dermatology facilitate tailored treatments using tretinoin formulations customized for skin type and condition, potentially expanding market segments.

5. Regulatory Shifts and OTC Accessibility:
   Moves to reclassify or restrict prescription-only status in key markets may impact revenue streams, necessitating strategic adjustments.

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Financial Projection and Strategic Outlook

The global tretinoin market was valued at approximately USD 400 million in 2021 and is projected to reach USD 620 million by 2030, reflecting steady growth driven by dermatological demand and expanded accessibility [1].

Branded formulations can expect revenue stability in mature markets due to brand recognition, though profit margins are thinning because of generic competition. Innovators who successfully develop differentiated formulations or combination therapies could capture higher premiums.

In emerging markets, rapid urbanization, increased disposable income, and expanding dermatology services will fuel demand. Entry strategies focusing on affordability and OTC availability may drive higher market penetration.

The profitability of RETIN-A products hinges on patent management, formulation innovation, and effective marketing. Companies that invest in formulation patents and strategic alliances—especially for niche or combination products—are well-positioned to extend product lifecycle and revenue.

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Challenges and Risks

• Pricing pressures from generics and OTC products reduce revenue potential.
• Regulatory hurdles may restrict access or increase compliance costs.
• Market saturation in developed regions limits growth without innovation.
• Competition from novel retinoids and combination therapies threaten to displace traditional tretinoin formulations.
• Consumer preferences shifting towards natural or organic skincare alternatives could impact demand.

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Key Takeaways

• The RETIN-A market remains robust but faces imminent challenges from generics, OTC proliferation, and alternative therapies.
• Innovation in formulation and combination products offers pathways to sustain premium pricing and market share.
• geographic expansion into emerging markets presents significant growth opportunities.
• Regulatory strategies and intellectual property management are critical in maintaining competitive advantage.
• Companies must adapt to shifting consumer preferences and technological advances to realize long-term financial success.

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FAQs

1. What is the primary driver behind RETIN-A’s continued market relevance?
Its proven efficacy in treating acne and photoaging, combined with a well-established safety profile, sustain its demand despite newer therapies.

2. How does patent expiration affect RETIN-A’s market dynamics?
Patent expirations open the market to generic competitors, exerting downward pressure on prices but also prompting innovation for branded formulations.

3. What role do combination therapies play in the future of tretinoin formulations?
They enhance efficacy, reduce side effects, and cater to consumer preferences for simplified skincare routines, providing a competitive edge.

4. How are regulatory changes impacting the accessibility of RETIN-A?
Reclassification from prescription to OTC status in some markets increases accessibility but may lead to greater market competition and pricing adjustments.

5. What emerging markets hold the most promise for RETIN-A sales growth?
Asia-Pacific and Latin American countries, due to rising skincare awareness, expanding dermatology services, and growing middle-class populations, offer substantial opportunities.

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References

[1] Research and Markets. "Global Topical Retinoids Market Forecast 2022-2030." 2022.