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RENOVA Drug Profile

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Which patents cover Renova, and when can generic versions of Renova launch?

Renova is a drug marketed by Valeant Pharms North and is included in two NDAs.

The generic ingredient in RENOVA is tretinoin. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renova

A generic version of RENOVA was approved as tretinoin by PERRIGO PHARMA INTL on December 24^th, 1998.

Summary for RENOVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1
Patent Applications:	4,098
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RENOVA
What excipients (inactive ingredients) are in RENOVA?	RENOVA excipients list
DailyMed Link:	RENOVA at DailyMed

See drug prices for RENOVA

Recent Clinical Trials for RENOVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dwight Owen	Phase 1

See all RENOVA clinical trials

Pharmacology for RENOVA

Drug Class

Retinoid

ATC Classes for RENOVA

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

US Patents and Regulatory Information for RENOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000		RX	Yes	Yes
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	AB2	RX	Yes	Yes

Expired US Patents for RENOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995

International Patents for RENOVA

Country	Patent Number	Estimated Expiration
Australia	1216983
South Korea	950014443
Germany	3440831
Australia	599135
Australia	5289686
European Patent Office	0230498
Japan	H0549642

Supplementary Protection Certificates for RENOVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322