RETIN-A-MICRO Drug Patent Profile

Which patents cover Retin-a-micro, 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-eight 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

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

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
Austria	68965
Australia	591264
Australia	7132287
Germany	3774266
European Patent Office	0285694	POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT

Supplementary Protection Certificates for RETIN-A-MICRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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	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
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506

Last updated: July 26, 2026

RETIN-A-MICRO (tretinoin) Investment Scenario and Fundamentals Analysis: Exclusivity, Patent/Orange Book Status, Generic Risk, and Commercial Outlook

Executive summary: RETIN-A-MICRO (tretinoin topical microsphere gel, 0.04% and 0.1%) is a mature OTC-to-prescription-era branded product in a low-to-moderate growth dermatology category. From an investment and IP standpoint, the key drivers are (1) whether any active Orange Book-listed patents still extend blocking rights for listed strengths and dosage forms, (2) whether FDA exclusivities (including pediatric exclusivity or data exclusivity) apply beyond patent term, (3) the likelihood of ANDA or 505(b)(2) conversions for the same dosage form/strengths, and (4) practical barriers like formulation-specific microsphere patents and bioavailability-in-topical evidence requirements. Without a current, verifiable Orange Book listing set and litigation docket for RETIN-A-MICRO, this analysis cannot be completed to an investable standard.