RETIN-A-MICRO Drug Patent Profile

When do Retin-a-micro patents expire, and what generic alternatives are available?

Retin-a-micro is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in RETIN-A-MICRO 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-micro

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

Summary for RETIN-A-MICRO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	6,226
DailyMed Link:	RETIN-A-MICRO at DailyMed

Pharmacology for RETIN-A-MICRO

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for RETIN-A-MICRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RETIN-A-MICRO	Gel	tretinoin	0.04%	020475	1	2010-12-20
RETIN-A-MICRO	Gel	tretinoin	0.1%	020475	1	2010-07-08

US Patents and Regulatory Information for RETIN-A-MICRO

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-MICRO	tretinoin	GEL;TOPICAL	020475-004	Oct 23, 2017		RX	Yes	Yes
Bausch	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-003	Jan 28, 2014	AB	RX	Yes	Yes

Expired US Patents for RETIN-A-MICRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-003	Jan 28, 2014

International Patents for RETIN-A-MICRO

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8806284
Australia	591264
Japan	2793188

Supplementary Protection Certificates for RETIN-A-MICRO

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

Market Dynamics and Financial Trajectory for RETIN-A-MICRO

Last updated: July 27, 2025

Introduction

RETIN-A-MICRO (tretinoin 0.04% and 0.1%) remains a pivotal dermatological treatment approved primarily for acne vulgaris. Originally developed by Ortho Dermatologics, a division of Johnson & Johnson, this topical retinoid has historically enjoyed a significant market presence. The evolving landscape of dermatology, compounded by generational shifts in patient preferences, regulatory shifts, and technological innovation, shapes its current and future market performance. This analysis dissects the key market dynamics and offers a projection of its financial trajectory, providing critical insights for stakeholders.

Market Overview

RETIN-A-MICRO’s market, primarily driven by dermatology clinics, prescription channels, and increasingly by online retail, has experienced notable shifts over the past decade. Its status as a long-standing first-line therapy for acne has cemented its position in dermatological therapeutics, although competition from generics and alternative treatments has introduced market pressures.

The global acne treatment market was valued at approximately USD 4.3 billion in 2022, with topical retinoids such as tretinoin accounting for a substantial segment. Despite the advent of new molecules and formulations, tretinoin retains a core position owing to its efficacy, safety profile, and well-established clinical track record.

Key Market Dynamics

1. Patent Expiry and Generic Competition

One of the most pivotal factors influencing RETIN-A-MICRO’s market is patent expiration. Ortho Dermatologics' original patent for tretinoin formulations expired in 2017, opening avenues for generic competition. Generic tretinoin products have proliferated, offering more affordable options, thus exerting downward pressure on prices and market share of branded formulations [1].

2. Regulatory and Patent Strategies

To extend market exclusivity, Johnson & Johnson introduced reformulated or branded derivatives, including RETIN-A-MICRO in 2000, emphasizing microencapsulation technology that purportedly enhances stability and efficacy. These innovations aimed to fend off generics, albeit with limited success as patent protections for specific formulations have been challenged or expired.

3. Prescribing Trends and Clinical Guidelines

Recent shifts in clinical guidelines favor combination therapies for acne, integrating tretinoin with antibiotics or oral agents, broadening or restricting its usage depending on patient profile. Patient preference towards topical formulations with minimal systemic side effects sustains its relevance, especially among adolescents and young adults.

4. Market Penetration and Patient Preferences

While oral isotretinoin and newer topical agents (e.g., adapalene, tazarotene) have gained popularity, tretinoin remains a preferred initial therapy due to its safety and familiarity. Increasing awareness about skin health and the rise in mild to moderate acne contribute favorably to long-term demand.

5. Impact of Digital and Retail Channels

Direct-to-consumer advertising and online pharmacies facilitate access but also introduce regulatory challenges. E-prescribing trends and telemedicine services further influence distribution channels. Meanwhile, price sensitivity prompts consumers to opt for generics.

6. Competitive Landscape

Major players include generic manufacturers, with some dermatology-focused companies innovating on formulation stability or delivery systems. The competition also involves other retinoids like adapalene and tazarotene, which sometimes outperform tretinoin on tolerability and tolerability.

7. Impact of COVID-19 Pandemic

Disrupted supply chains and altered healthcare access temporarily reduced prescriptions but have since rebounded. Teledermatology has expanded, providing new avenues for prescribing tretinoin-based products, including RETIN-A-MICRO.

Financial Trajectory Analysis

Historical Financial Performance

Historically, RETIN-A-MICRO generated peak revenues shortly after its introduction owing to its innovation status. Annual sales peaked in the early 2000s, with estimates reaching over USD 300 million in the U.S. alone (before patent expiry). Following patent cliffs, sales declined markedly, with significant revenue drop in generic eras.

Current Market Valuation

As of 2023, branded RETIN-A-MICRO’s market share resides primarily within niche dermatology markets, with revenues estimated around USD 50-70 million annually in the U.S., contrasting sharply with the peak period. Global revenues remain dominated by generic sales, diluting the commercial impact of the original brand.

Future Revenue Projections

Forecasting suggests a modest decline in branded RETIN-A-MICRO revenues over the next 5 years unless new formulations or delivery mechanisms are introduced. The significant global market for tretinoin, however, remains robust, bolstered by generic sales and over-the-counter (OTC) options in select markets.

1. Patent Stability & Innovation: If Johnson & Johnson or successors develop new delivery forms—such as slow-release patches, microspheres, or combined formulations—these could buoy revenues, targeting niche segments.

2. Market Penetration Strategies: Strategic collaborations with online pharmacies and telemedicine providers may expand access, particularly among younger demographics.

3. Pricing Strategies: Given the commoditization, aggressive pricing and bundling with other dermatological therapies could influence sales volume.

4. Regulatory Landscape: Approval of OTC status in certain markets or substitution policies favoring generics could diminish profits but broaden consumption.

Risks and Opportunities

• Risks: Market saturation with generics, regulatory restrictions, and evolving treatment paradigms may constrain growth.
• Opportunities: Innovations in delivery, combination therapies, and targeted marketing to millennials and Gen Z patients present growth routes.

Conclusion

The market dynamics for RETIN-A-MICRO exemplify the challenges and opportunities faced by established dermatological drugs amid patent expirations and intensifying competition. While its brand-specific revenues have declined, the global tretinoin market remains sizeable, driven by generics and OTC formulations. Financially, the outlook indicates stability with potential for growth through innovation and strategic market positioning.

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Key Takeaways

• Patent expirations have significantly diminished RETIN-A-MICRO’s market exclusivity, leading to heightened generic competition.
• Market size remains robust in global dermatology, but globally branded revenues face pressure unless supplemented by innovative formulations.
• Formulation innovation, such as sustained-release or combination regimens, could revitalize brand revenue streams.
• Digital channels and teledermatology expand access, influencing prescribing trends and market share.
• Strategic adaptation, including value-added products and diversified distribution, is essential to sustain financial performance.

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FAQs

1. How does generic competition impact RETIN-A-MICRO’s profitability?
Generic tretinoin formulations significantly reduce the market share and profit margins of the original brand by offering lower-cost alternatives, often resulting in a sharp decline in branded product revenues post-patent expiry.

2. What innovations could extend RETIN-A-MICRO’s market life?
Delivery system advancements like sustained-release patches, microencapsulation, or combination therapies with other dermatological agents can enhance efficacy, tolerability, and market appeal, potentially revitalizing sales.

3. How has the COVID-19 pandemic influenced the usage of tretinoin products?
The pandemic temporarily disrupted supply chains and prescription processes but accelerated telemedicine adoption, facilitating continued prescribing and access to tretinoin through digital channels.

4. What are the main competitive molecules for RETIN-A-MICRO?
Adapalene (Differin) and tazarotene serve as key competitors due to similar efficacy with improved tolerability profiles, impacting RETIN-A-MICRO’s market share.

5. What strategic moves should pharmaceutical companies consider to capitalize on tretinoin’s market?
Companies should focus on innovative delivery mechanisms, expanding access via digital and retail channels, and exploring OTC opportunities, all while ensuring compliance with evolving regulatory landscapes.

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References

[1] MarketResearch.com, “Global Acne Treatment Market,” 2022.