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:	140
Drug Prices:	Drug price information for RETIN-A MICRO
What excipients (inactive ingredients) are in RETIN-A MICRO?	RETIN-A MICRO excipients list
DailyMed Link:	RETIN-A MICRO at DailyMed

See drug prices for RETIN-A MICRO

Pharmacology for RETIN-A MICRO

Drug Class

Retinoid

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	020475-002	May 10, 2002		RX	Yes	Yes
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997		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	020475-002	May 10, 2002
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002

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
Japan	S63256126	MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM
Australia	7132287

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
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

Market Dynamics and Financial Trajectory for RETIN-A MICRO

Last updated: July 29, 2025

Overview of RETIN-A MICRO

RETIN-A MICRO, a topical formulation of tretinoin encapsulated in microsphere technology, is predominantly prescribed for the treatment of acne vulgaris and has also found off-label uses in photoaging management. Developed by Allergan, now part of AbbVie, RETIN-A MICRO offers improved stability and controlled release, enhancing tolerability and efficacy in comparison to traditional tretinoin formulations. Its unique delivery system has positioned it as a market leader within topical retinoids, influencing its market dynamics and revenue trajectory.

Market Landscape

Global Market Size and Growth

The global dermatology drug market, driven by an increasing prevalence of dermatological conditions and expanding aging populations, is projected to register a compound annual growth rate (CAGR) of approximately 8% from 2022 to 2027, reaching USD 44 billion by 2027 [1]. Retinoids, including RETIN-A MICRO, constitute a significant fraction of this market, fueled by their broad applicability and longstanding clinical acceptance.

Specifically, the acne therapeutics segment is valued at over USD 9 billion globally, with topical retinoids accounting for roughly 30-40% of prescriptions [2]. RETIN-A MICRO's niche, owing to its microsphere technology, has allowed it to command a premium pricing position, cementing its hold in mature markets such as North America and Europe.

Key Drivers of Market Growth

1. Rising Acne Prevalence: Affecting over 85% of adolescents and young adults at some stage, acne creates a sustained demand for effective therapies [3].
2. Aging Population and Photoaging: The growing desire among older adults for skin rejuvenation fosters off-label use of tretinoin formulations.
3. Innovation in Drug Delivery: Microsphere technology enhances drug tolerability and efficacy, differentiating RETIN-A MICRO from competitors.
4. Increasing Awareness and Accessibility: Campaigns and digital health initiatives increase patient awareness, boosting prescriptions.

Market Challenges and Constraints

• Patent Expiry and Generic Competition: With patent protections set to expire around 2025, generic formulations threaten revenue streams.
• Pricing Pressure: Payor and formulary constraints induce price reductions, especially for non-branded retinoid products.
• Side Effect Profile: Tretinoin-related irritation limits use among sensitive populations, affecting market penetration.
• Regulatory and Legal Risks: Ongoing litigation over formulary placements and patent disputes may impact market stability.

Financial Trajectory and Revenue Outlook

Historical Performance and Revenue Trends

RETIN-A MICRO has historically delivered robust sales for AbbVie’s dermatology portfolio, with annual revenues estimated at USD 250–300 million prior to patent expiration activities [4]. The drug's premium pricing, driven by its unique delivery system, sustained healthy margins.

Forecasted Revenue Post-Patent Expiry

As the patent lapses over the next 1–2 years, market analysts project a decline in branded RETIN-A MICRO revenues of approximately 20–30% annually unless mitigated by new formulations or indications. The entry of generic tretinoin microsphere equivalents is expected to depress the price point, causing revenue erosion.

However, AbbVie’s strategic efforts include:

• Line Extensions: Developing related formulations for broader dermatological uses.
• New Indications: Pursuing clinical trials for indications such as photoaging and keratosis.
• Combination Therapies: Integrating tretinoin with other anti-acne agents for enhanced efficacy.

These initiatives aim to sustain top-line growth, offsetting losses from generic competition.

Strategic Pricing and Market Penetration

In mature markets, pricing differentiation is conventional. While generics offer lower-cost options, RETIN-A MICRO retains a market niche due to:

• Perceived Superior Efficacy: Encouraged by controlled-release technology.
• Brand Loyalty and Physician Preference: Established dermatologists favor consistent results.
• Formulation Advantages: Reduced irritation and improved compliance.

Therefore, revenue trajectories will depend heavily on the pace of generic market share gain and the success of pipeline expansion efforts.

Competitive Landscape

Major Competitors and Alternatives

• Generic tretinoin formulations: Lower-cost options that erode branded sales.
• Other retinoid products: Differin (adapalene), Tazorac (tazarotene), and newer agents like tretinoin gel formulations.
• Emerging topical anti-aging agents: Peptides, antioxidants, and novel delivery systems.

Differentiation and Market Positioning

RETIN-A MICRO’s microencapsulation technology grants a competitive edge via superior tolerability and dosing convenience. Nevertheless, price competition from generics and alternative formulations exerts downward pressure.

Pipeline and Innovation Impact

AbbVie's R&D pipeline includes novel retinoids with enhanced safety profiles and newer delivery systems. If successful, these could disrupt the current market and extend revenue longevity beyond traditional patent life cycles.

Regulatory and Patent Outlook

Patent protection for RETIN-A MICRO remains active until 2024–2025, after which generic competition will intensify. AbbVie may seek to extend market exclusivity through formulation patents or new therapeutic indications, as permitted under regulatory frameworks.

Regulatory bodies, like the FDA, continue to evaluate safety profiles, especially concerning long-term use and irritation potential, which could influence market penetration and prescribing guidelines.

Market Risks and Opportunities

• Risks: Patent expiration, pricing compression, regulatory changes, and competition from off-label therapies.
• Opportunities: Expanding indications, innovating delivery systems, and entering emerging markets.

Conclusion

RETIN-A MICRO’s current market position is shaped by its technological superiority and entrenched brand presence. Pending patent expiration, the drug faces significant revenue erosion unless mitigated by pipeline innovation and strategic diversification. The market is poised for moderate growth driven by demographic changes and technological advancements, with opportunities to sustain its financial trajectory through product innovation and geographic expansion.

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Key Takeaways

• RETIN-A MICRO is a leading topical retinoid benefiting from microsphere technology, commanding premium pricing in mature markets.
• Patent expiration around 2024–2025 will catalyze increased generic penetration, posing revenue risks.
• AbbVie’s pipeline and formulation innovations aim to extend product lifecycle and market share.
• The global acne treatment market’s growth, coupled with aging population trends, will sustain demand, though price pressures intensify.
• Strategic focus on new indications and market expansion is critical for maintaining profitability.

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FAQs

Q1. When will patent protection for RETIN-A MICRO expire, and what does it mean for market competition?
Patent protection is expected to expire around 2024–2025, which will likely lead to increased generic competition, exerting downward pressure on prices and revenues.

Q2. How does RETIN-A MICRO’s delivery technology influence its market position?
Its microsphere encapsulation offers improved tolerability, controlled drug release, and patient compliance, differentiating it from traditional tretinoin formulations and supporting premium pricing.

Q3. What strategic initiatives are AbbVie pursuing to prolong RETIN-A MICRO’s market life?
AbbVie focuses on developing new formulations, exploring additional indications, and expanding into emerging markets to offset revenue losses from generic competitors.

Q4. How does the competitive landscape impact future revenues of RETIN-A MICRO?
Generic tretinoin formulations and OTC alternatives increase competitive pressure, risking significant revenue declines unless differentiated or coupled with effective marketing and pipeline innovations.

Q5. What are the primary growth drivers for the dermatology market influencing RETIN-A MICRO?
Increasing acne prevalence, aging population seeking skin rejuvenation, advances in drug delivery technology, and rising awareness contribute significantly to the sector’s growth.

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References

[1] MarketWatch. "Global Dermatology Drugs Market Size, Share & Trends Analysis." 2022.
[2] IQVIA. "Dermatology Prescription Trends and Market Share Reports." 2022.
[3] NIH. "Epidemiology of Acne." 2020.
[4] AbbVie Annual Reports. "Financial Performance of Dermatology Portfolio." 2022.