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-two 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
Formulation / Manufacturing:	see details
DailyMed Link:	RETIN-A-MICRO at DailyMed

Pharmacology for RETIN-A-MICRO

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for RETIN-A-MICRO

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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
Japan	2909078
Japan	S63256126	MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM
South Africa	8906012
South Korea	960013701
Australia	603379
Greece	3003064
Australia	2164088

Supplementary Protection Certificates for RETIN-A-MICRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
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
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	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018