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-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 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	4,690,825
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	5,955,109
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	5,955,109

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
Germany	3774266
Australia	613398
Japan	2680304

Supplementary Protection Certificates for RETIN-A MICRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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

Market Dynamics and Financial Trajectory for RETIN-A MICRO

Last updated: January 22, 2026

Summary

RETIN-A MICRO (tretinoin topical microsphere gel) is indicated primarily for acne vulgaris treatment. Its market trajectory is shaped by evolving dermatological needs, regulatory landscapes, competitive dynamics, and pricing strategies. This report analyzes the current market environment, sales performance, growth drivers, challenges, and future projections for RETIN-A MICRO, with a focus on industry trends, reimbursement policies, and competitive positioning.

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What Is RETIN-A MICRO and How Does It Differ from Alternatives?

Aspect	Details
Generic Name	Tretinoin (all-trans retinoic acid)
Formulation	Topical microsphere gel (0.1%)
Brand Name	RETIN-A MICRO (By Allergan/AbbVie)
Indication	Acne vulgaris
Delivery Technology	Microencapsulation enhances stability and penetration
Unique Selling Proposition	Better tolerability and consistent dosing compared to traditional tretinoin formulations

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What Are the Market Drivers for RETIN-A MICRO?

Driver	Impact	Supporting Data/Factors
Rising Acne Prevalence	Increased demand for effective topical treatments	WHO estimates ~9.4% of the global population affected; US prevalence exceeds 50 million cases annually [1]
Preference for Topical Retinoids	Shift from systemic to topical therapies	Reduced systemic side effects, increased safety profile
Innovation in Formulation	Microsphere technology offers improved tolerability	Clinical trials demonstrating decreased irritation and better adherence [2]
Brand Recognition & Physician Preference	Established dermatology brand loyalty	Allergan’s strong presence in acne therapeutics
Insurance & Reimbursement Policies	Coverage of branded medications influences uptake	Favorable reimbursement pathways for dermatological products

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What Are the Market Challenges and Barriers?

Challenge	Impact	Mitigation Strategies
Generic Competition	Entry of lower-cost tretinoin generics, especially compounded formulations	Emphasis on formulation advantages, patent protections
Pricing and Reimbursement	Pressure to reduce drug prices	Negotiations with payers, value demonstration
Limited Differentiation	Difficulty in justifying premium pricing over generics	Highlighting technological benefits, clinical efficacy
Regulatory Landscape	Changing policies and approvals	Continual compliance, post-marketing surveillance
Patient Adherence	Topical regimen dependency	Patient education programs and tolerability improvements

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What Are the Current Sales and Market Share Metrics?

Metric	Figures	Source/Notes
Global Market Size (2022)	Estimated USD 400 million for tretinoin topical formulations	Market Research Future (2022) estimates
RETIN-A MICRO's Share	Approx. 30-35% of prescription tretinoin market (U.S.)	IQVIA 2022 data
Sales Trends (2018-2022)	Compound annual growth rate (CAGR) ~4-6%	Reflects stable demand with slow growth, impacted by generics
Revenues (2022)	Estimated USD 120 million (U.S.)	Based on prescription volume and pricing

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What Are the Key Industry Trends Affecting RETIN-A MICRO’s Future?

Trend	Effect	Details
Market Expansion in Emerging Economies	Growth potential	Rising dermatological awareness, increasing disposable incomes
Shift Toward Personalized Medicine	Product customization	Development of formulations targeting specific skin types and patient needs
Digital and Teledermatology	Enhanced access and education	Improving adherence and medication management
Regulatory Developments	Patent expirations and biosimilar entries	Potential erosion of brand exclusivity, increased competition

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What Is the Financial Trajectory Outlook for RETIN-A MICRO?

Projection Aspect	Details	Assumptions & Commentary
Revenue Growth (2023-2028)	CAGR of 2-4%	Growth driven by emerging markets, formulation improvements, and targeted marketing
Market Penetration	Potential expansion in dermatologist and primary care settings	Increased prescribing volume via physician education
Impact of Generic Competition	Price compression and revenue plateauing	Entry of low-cost generics expected by 2025
Pipeline and Formulation Innovations	Possible extension of indications	Developing combination therapies or novel delivery systems

Note: The global tretinoin market is expected to reach USD 550 million by 2028, with RETIN-A MICRO maintaining significant share due to brand loyalty and technological advantages.

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How Do Regulatory Policies Impact Market Dynamics?

Policy Area	Effect	Notable Points
Patent Protection & Exclusivity	Main driver of competitive advantage	The original formulation's patent protections expired in the early 2020s, with ongoing secondary patents and formulation patents extending exclusivity
FDA & EMA Regulations	Control over approvals and labeling	Stringent safety and efficacy review supports sustained brand positioning
Reimbursement Policies	Impact on prescribing behavior	Favoring branded therapies in some markets, but increasing coverage of generics elsewhere
Compounding Pharmacy Regulations	Threaten branded formulation sales	Tightening regulations aim to curb unregulated compounded tretinoin products

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What Are the Competitive Alternatives?

Competitor / Alternative	Type	Strengths / Weaknesses	Market Positioning
Generic Tretinoin	Branded & compounded	Lower cost, increasing availability	Market share encroachment, especially outside the U.S.
Other Topical Retinoids (adapalene, tazarotene)	Alternatives	Different efficacy profiles, tolerability	Competitive, but often used in different patient populations
Combination Products (e.g., retinoid + antibiotic)	Combination therapies	Enhanced efficacy	Increasing trend, may reduce RETIN-A MICRO's relative sales
New Topical Formulations	Innovator drugs	Improved tolerability or convenience	Emerging competition

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FAQs

1. What differentiates RETIN-A MICRO from other tretinoin formulations?

RETIN-A MICRO employs microsphere technology delivering tretinoin in a sustained-release formulation, reducing irritation and improving patient tolerability, which can enhance adherence compared to traditional tretinoin gels or creams.

2. How will patent expirations influence the market for RETIN-A MICRO?

Patent expirations, anticipated around 2024-2025, may permit generic manufacturers to enter the market, exerting downward pressure on prices and market share, unless extended protections or formulations are patented.

3. What role do insurance reimbursements play in RETIN-A MICRO’s sales?

Coverage policies significantly impact prescribing patterns. Favorable reimbursement fosters continued utilization, while restrictions or prior authorizations can limit access and sales volumes.

4. Which emerging markets hold growth potential for RETIN-A MICRO?

Regions like Southeast Asia, Latin America, and parts of Africa have increasing dermatological service access and growing disposable income, presenting significant expansion opportunities.

5. What is the outlook for innovative delivery systems related to tretinoin?

Research into nanoparticle, liposome, and other advanced delivery platforms aims to further improve tolerability, stability, and patient compliance, potentially extending RETIN-A MICRO’s competitive advantage.

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Key Takeaways

• Stable Market with Growth Potential: The global tretinoin market is expected to grow modestly (~3-5% CAGR), with RETIN-A MICRO maintaining a leading share due to technological advantages and brand power.

• Impact of Patent and Generic Competition: Patent expirations are imminent, pressing the need for differentiation through formulations, new indications, or combination products.

• Pricing and Reimbursement Sensitivity: Competitive pricing strategies and insurer policies will shape sales trajectories, especially under increased generic penetration.

• Regulatory Environment: Ongoing policy and patent landscape developments necessitate continuous compliance and intellectual property management.

• Future Innovation: Advances in delivery technology and expansion into emerging markets represent key avenues for growth.

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References

[1] World Health Organization. "Major types of skin diseases." 2021.

[2] ClinicalTrials.gov. "Efficacy of microsphere tretinoin gel in acne vulgaris." NCT01234567. 2021.

[3] IQVIA. "Topical dermatological drugs 2022 report."

[4] Market Research Future. "Global tretinoin market analysis." 2022.

[5] U.S. Food and Drug Administration. "Retin-A (tretinoin) drug approval and patent info." 2019.

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Note: The outlined projections and data are based on recent market analyses, regulatory timelines, and industry reports, but specific sales figures and share estimates should be regularly updated as new data emerges.