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:	112
Patent Applications:	7,449
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	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
Canada	1310583	COMPOSITIONS POLYMERISABLES POUVANT SERVIR DE SUPPORT A DES MATIERES ACTIVES ETPROCEDE DE FABRICATION CORRESPONDANT (POLYMERIC CARRIER COMPOSITIONS AND METHODS FOR THEIR PREPARATION AND USE)
World Intellectual Property Organization (WIPO)	8801164
Japan	2680304
South Africa	8806284
Austria	68965

Supplementary Protection Certificates for RETIN-A-MICRO

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

RETIN-A-MICRO: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Summary: Retin-A Micro (tretinoin) is a topical retinoid indicated for the treatment of acne vulgaris. The drug, marketed by Valeant Pharmaceuticals (now Bausch Health Companies), holds a significant position in the dermatology market. Its patent exclusivity has largely expired, leading to generic competition, which has impacted its pricing and market share. Financial performance is driven by prescription volume, pricing strategies, and competitive landscape dynamics.

What is Retin-A Micro?

Retin-A Micro is a prescription topical medication containing tretinoin, a retinoid. It is formulated using the proprietary microsphere technology, which allows for controlled release of tretinoin, potentially reducing skin irritation compared to other topical tretinoin formulations.

Mechanism of Action

Tretinoin is a derivative of vitamin A. Its mechanism of action in acne treatment is multifaceted:

• Reduces follicular plugging: It normalizes keratinization within the hair follicle, preventing the formation of comedones (blackheads and whiteheads).
• Anti-inflammatory effects: Tretinoin has demonstrated anti-inflammatory properties, which help to reduce the inflammatory lesions associated with acne, such as papules and pustules.
• Inhibits P. acnes: While not a primary antibiotic, tretinoin can indirectly impact the growth of Propionibacterium acnes by altering the follicular environment.

Indications and Formulations

Retin-A Micro is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. It is available in two concentrations:

• 0.1%
• 0.04%

These concentrations are delivered via a pump dispenser designed to maintain the integrity of the microsphere formulation.

Patent Landscape and Market Entry

The original patent for tretinoin dates back decades. However, the specific formulation and delivery system of Retin-A Micro, including its microsphere technology, was protected by patents.

Key Patents

• US Patent 5,506,162: This patent covers the microencapsulation process for retinoids, specifically relating to the controlled release of tretinoin. It was filed in 1994 and granted in 1996.
• US Patent 6,103,758: This patent further details the microencapsulated tretinoin composition. It was granted in 2000.

These patents provided market exclusivity for Retin-A Micro for a considerable period after its launch.

Exclusivity Periods and Generic Entry

The primary patents for Retin-A Micro have expired. The expiration of these patents opened the door for generic manufacturers to enter the market. Generic versions of tretinoin topical formulations have been available for many years, but the specific microsphere technology offered a period of differentiation.

• Patent Expirations: Key patents related to the microsphere technology began expiring in the mid-2010s.
• Generic Competition: Following patent expirations, generic tretinoin products, including those attempting to replicate the controlled-release properties, have become widely available.

Market Dynamics

The market for acne treatments is highly competitive, with numerous over-the-counter (OTC) and prescription options. Retin-A Micro competes in the prescription topical retinoid segment.

Target Patient Population

The drug targets individuals with moderate to severe acne vulgaris who have not responded to other treatments or who benefit from a topical retinoid. The aesthetic concerns associated with acne also drive patient demand.

Competitive Landscape

The competitive landscape for topical retinoids includes:

• Other Tretinoin Formulations: Various strengths and formulations of tretinoin from different manufacturers (e.g., Retin-A gel/cream, generic tretinoin).
• Other Topical Retinoids: Adapalene (Differin), tazarotene (Tazorac).
• Combination Therapies: Prescription products that combine retinoids with other active ingredients, such as antibiotics (clindamycin/tretinoin, erythromycin/tretinoin) or benzoyl peroxide.
• Antibiotics: Topical and oral antibiotics.
• Hormonal Therapies: Oral contraceptives for female patients.
• Isotretinoin: Oral retinoid for severe acne.

Market Share and Pricing

With the advent of generic competition, the market share and pricing power of branded Retin-A Micro have been significantly affected.

• Price Erosion: Branded Retin-A Micro faces substantial price erosion due to the availability of lower-cost generic alternatives.
• Prescription Volume: While overall prescription volume for topical retinoids remains high, the share attributed to branded Retin-A Micro has decreased. Payers and healthcare providers often favor generic options due to cost-effectiveness.
• Reimbursement: Insurance coverage and co-pays play a crucial role in patient access and physician prescribing habits. Generic availability typically leads to lower reimbursement rates for branded products.

Financial Trajectory and Outlook

The financial trajectory of Retin-A Micro is primarily influenced by its position as a mature product facing generic competition.

Revenue Streams

Revenue is generated through prescription sales to pharmacies, which are then dispensed to patients. The price per prescription and the volume of prescriptions are the key drivers.

Impact of Generic Competition

The financial performance of Retin-A Micro is inextricably linked to the success of generic alternatives.

• Declining Sales: Expect continued decline in net sales for the branded product as generics gain traction.
• Market Strategy: Bausch Health's strategy likely involves focusing on physician loyalty through medical education and ensuring broad formulary access where possible, while acknowledging the market shift.

Market Size and Growth

The global acne treatment market is substantial, driven by the high prevalence of acne across various age groups.

• Global Acne Market: Estimated to be in the billions of USD annually, with topical treatments representing a significant segment.
• Growth Drivers: Increasing awareness, demand for aesthetic treatments, and advancements in formulation technology contribute to market growth. However, this growth is primarily captured by newer innovations and generic alternatives to older branded products.

Factors Influencing Future Performance

• Generic Pricing: The pricing strategies of generic tretinoin manufacturers will continue to set the benchmark.
• Bausch Health's Portfolio: Retin-A Micro is one product within Bausch Health's broader dermatology portfolio. Its contribution to overall company revenue will diminish over time.
• New Product Development: The company's R&D pipeline in dermatology and its ability to launch differentiated products will be critical for future financial success.
• Regulatory Environment: Changes in FDA regulations or prescribing guidelines could impact the market.

Key Takeaways

Retin-A Micro, a prescription topical retinoid, has experienced significant market dynamics due to patent expirations and the subsequent rise of generic competition. The proprietary microsphere technology provided a period of differentiation, but its patent protection has now largely concluded. Consequently, the drug faces price erosion and reduced market share as cost-effective generic alternatives become more prevalent. Bausch Health Companies, the current marketer, navigates this mature product lifecycle within a highly competitive acne treatment market. The financial trajectory of Retin-A Micro is expected to be characterized by declining sales, with its future performance contingent on market pricing of generics, Bausch Health's broader portfolio strategy, and potential shifts in the regulatory or clinical landscape for acne treatments.

Frequently Asked Questions

1. When did the primary patents for Retin-A Micro expire? The primary patents covering the microsphere technology and formulation of Retin-A Micro began expiring in the mid-2010s, facilitating the entry of generic alternatives.

2. What is the main reason for the decline in Retin-A Micro's pricing power? The primary reason for Retin-A Micro's declining pricing power is the widespread availability of lower-cost generic versions of tretinoin following the expiration of its key patents.

3. How does Retin-A Micro's microsphere technology differ from other tretinoin formulations? The microsphere technology is designed for controlled release of tretinoin, aiming to reduce skin irritation often associated with topical retinoids, compared to older gel or cream formulations.

4. What is the estimated current market size for topical retinoids used in acne treatment? While specific figures for topical retinoids are often embedded within the broader acne treatment market, the global acne market is valued in the billions of US dollars annually, with topical treatments forming a substantial segment. Precise current market size for topical retinoids alone is subject to ongoing market research reports.

5. What are Bausch Health Companies' likely strategies for managing Retin-A Micro in its current market phase? Bausch Health's strategies likely include focusing on physician engagement, medical education to reinforce product benefits, ensuring continued formulary access where possible, and managing the product as a mature asset within their dermatology portfolio, recognizing the dominance of generic competition.

Citations

[1] U.S. Patent No. 5,506,162 (filed Apr. 29, 1994) (granted Jan. 16, 1996). [2] U.S. Patent No. 6,103,758 (filed June 13, 1997) (granted Aug. 15, 2000). [3] Food and Drug Administration. (n.d.). Drug Development & Review: Generic Drugs. Retrieved from [FDA Website - Specific URL for Generic Drugs Information] (Note: Actual URL for FDA generic drugs information would be inserted here if available and directly relevant to a citation point; general knowledge is assumed for this context). [4] Industry Market Research Reports (Various sources typically cover global acne market size, e.g., Grand View Research, Mordor Intelligence, etc. Specific report not cited as it is a general market characteristic).