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Valeant Intl Company Profile

VALEANT INTL has eleven approved drugs.

There are two US patents protecting VALEANT INTL drugs.

There are twenty patent family members on VALEANT INTL drugs in eleven countries and thirty-nine supplementary protection certificates in thirteen countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Intl	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Valeant Intl	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003	AB	RX	Yes	No	6,923,984	➤ Sign Up	Y			➤ Sign Up
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		➤ Sign Up				➤ Sign Up
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Valeant Intl	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	AB	RX	Yes	No	7,108,866	➤ Sign Up	Y			➤ Sign Up
Valeant Intl	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	AB	RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	4,472,380*PED	➤ Sign Up
Valeant Intl	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-001	Nov 5, 1982	3,562,257	➤ Sign Up
Valeant Intl	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	5,529,791	➤ Sign Up
Valeant Intl	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	5,288,505	➤ Sign Up
Valeant Intl	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-003	Jan 28, 2014	5,955,109	➤ Sign Up
Valeant Intl	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	4,690,825	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Gel	0.1%	➤ Subscribe	2010-07-08
➤ Subscribe	Extended-release Tablets	120 mg, 180 mg, 240 mg, 300 mg and 360 mg	➤ Subscribe	2005-08-30
➤ Subscribe	Extended-release Tablets	150 mg and 300 mg	➤ Subscribe	2004-09-21
➤ Subscribe	Gel	0.04%	➤ Subscribe	2010-12-20
➤ Subscribe	Extended-release Tablets	420 mg	➤ Subscribe	2005-04-25

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	CR 2017 00062	Denmark	➤ Sign Up	PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
1304992	2013C/060	Belgium	➤ Sign Up	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
0656775	CR 2000 00018	Denmark	➤ Sign Up	PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
1304992	1390049-3	Sweden	➤ Sign Up	PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
0617614	C300043	Netherlands	➤ Sign Up	PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
0591275	SPC/GB05/030	United Kingdom	➤ Sign Up	PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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