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:	3
Raw Ingredient (Bulk) Api Vendors:	140
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
Australia	613398
Australia	603379
Germany	3774266
Germany	3880593

Supplementary Protection Certificates for RETIN-A-MICRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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	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

RETIN-A-MICRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RETIN-A MICRO

Introduction

RETIN-A MICRO, a topical acne treatment containing tretinoin, has been a significant player in the dermatological market since its launch in the U.S. in 1997. Here, we delve into the market dynamics and financial trajectory of this product.

Market Launch and Initial Success

RETIN-A MICRO was the first ethical pharmaceutical to incorporate the patented Microsponge(R) delivery system, which enhances the delivery and stability of tretinoin. This innovation led to its rapid acceptance in the U.S. market, making it one of the leading products in the $500 million-per-year U.S. prescription acne market[1].

Expansion to Canada

In 2001, RETIN-A MICRO received marketing clearance in Canada, where it was marketed by Johnson & Johnson Canada under the same trade name. This expansion was anticipated to add to the existing royalty streams for A.P. Pharma, the company behind the Microsponge(R) technology[1].

Product Formulations and Approvals

The original formulation of RETIN-A MICRO, which contained 0.1% tretinoin, was followed by a new, lower-dose formulation of 0.04% tretinoin gel, approved by the U.S. FDA in May 2002. This second formulation was expected to be launched in June 2002 and had the potential to significantly increase A.P. Pharma's royalties[5].

Market Drivers

Several factors drive the demand for RETIN-A MICRO:

Skincare and Cosmetics Market

The growing demand for skincare products, particularly those with anti-aging and skin-renewing properties, has been a key driver. Tretinoin, a vitamin A derivative, is frequently used in these formulations due to its efficacy in treating various dermatological conditions[3].

Prescription Market

RETIN-A MICRO is a prescription-only drug, and its demand is driven by the need for efficient and scientifically validated treatments for acne and other skin issues. Dermatologists often recommend tretinoin for various skin conditions, further boosting its market presence[3].

Patient Preference for Topical Treatments

Patients often prefer topical treatments for dermatological problems, which fuels the demand for RETIN-A MICRO and other tretinoin-containing products[3].

Distribution Channels

RETIN-A MICRO is primarily distributed through:

Pharmacies and Drugstores

Stronger formulations, particularly those for specific dermatological conditions, are dispensed through prescription by healthcare professionals in pharmacies and drugstores[3].

Online Retail

The growing trend of online retail has also made tretinoin-containing products, including RETIN-A MICRO, available through e-commerce platforms[3].

Geographic Market Presence

North America

RETIN-A MICRO has a strong presence in the U.S. and Canada, where it is marketed by Johnson & Johnson companies. The North American market is a significant contributor to the product's revenue[1][3].

Global Expansion

While the primary focus has been on North America, the global skincare market trends suggest potential for expansion into other regions, including Europe, Asia-Pacific, and Latin America[3].

Financial Trajectory

Royalty Streams

A.P. Pharma, the developer of the Microsponge(R) technology, receives royalties on the sales of RETIN-A MICRO. The approval and launch of the 0.04% formulation were expected to significantly increase these royalty payments[5].

Revenue Impact

The launch of RETIN-A MICRO in Canada and the introduction of the new 0.04% formulation were anticipated to add to A.P. Pharma's existing royalty streams, contributing to the company's financial growth[1][5].

Market Size and Growth

The tretinoin market, which includes products like RETIN-A MICRO, was valued at USD 2.5 billion in 2024 and is projected to reach USD 7.5 billion by 2031, growing at a CAGR of 10.1% during the forecast period. This growth is driven by the expanding skincare and cosmetics sector, among other factors[3].

Key Players and Partnerships

RETIN-A MICRO is marketed by Ortho Dermatological, a member of the Johnson & Johnson family of companies, under a licensing agreement with A.P. Pharma. This partnership has been crucial in the product's success and the financial benefits accrued by A.P. Pharma[1].

Clinical and Operational Developments

The success of RETIN-A MICRO has also driven A.P. Pharma to invest in the development and commercialization of other bioerodible delivery systems, such as the Biochronomer(TM) systems, which are designed for the controlled release of drugs into various sites[1].

Conclusion

RETIN-A MICRO has established itself as a leading product in the topical prescription acne market, driven by its innovative delivery system and strong market demand. The product's financial trajectory is marked by significant royalty streams for A.P. Pharma and a growing market presence both in North America and potentially globally.

Key Takeaways

• Innovative Delivery System: RETIN-A MICRO's Microsponge(R) technology has been a key factor in its success.
• Strong Market Demand: Driven by the skincare and cosmetics market, patient preference for topical treatments, and dermatologist recommendations.
• Geographic Expansion: Successful launches in the U.S. and Canada with potential for further global expansion.
• Financial Growth: Significant royalty streams for A.P. Pharma from product sales.
• Market Growth: Part of a larger tretinoin market projected to grow at a CAGR of 10.1% from 2024 to 2031.

FAQs

Q: What is the primary active ingredient in RETIN-A MICRO?

A: The primary active ingredient in RETIN-A MICRO is tretinoin, a vitamin A derivative.

Q: When was RETIN-A MICRO first launched in the U.S.?

A: RETIN-A MICRO was first launched in the U.S. in 1997.

Q: What is the Microsponge(R) delivery system?

A: The Microsponge(R) delivery system is a patented technology that enhances the delivery and stability of tretinoin in RETIN-A MICRO.

Q: Who markets RETIN-A MICRO in Canada?

A: RETIN-A MICRO is marketed in Canada by Johnson & Johnson Canada.

Q: What is the projected growth rate of the tretinoin market from 2024 to 2031?

A: The tretinoin market is projected to grow at a CAGR of 10.1% from 2024 to 2031.

Sources

1. Retin-A Micro Receives Marketing Clearance in Canada; Johnson & Johnson Canada to Market Prescription Acne Treatment Containing Microsponge Systems in Canada. Heron Therapeutics.
2. EyePoint Pharmaceuticals Reports Fiscal First Quarter 2019 Financial Results and Highlights Recent Clinical and Operational Developments. EyePoint Pharmaceuticals.
3. Tretinoin Market Size, Share, Scope, Trends And Forecast. Verified Market Research.
4. Retinol Market Size, Share & Growth Analysis Report, 2030. Grand View Research.
5. Second Formulation of RETIN-A MICRO Approved for U.S. Market; Launch Anticipated in June 2002; Potential to Significantly Increase A.P. Pharma's Royalties. Heron Therapeutics.