Vale Company Profile

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VALE has seventy-two approved drugs.

There are six US patents protecting VALE drugs.

There are forty-four patent family members on VALE drugs in twelve countries and fifty supplementary protection certificates in fifteen 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 Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharm Intl	LIBRELEASE	chlordiazepoxide	CAPSULE, EXTENDED RELEASE;ORAL	017813-001	Sep 12, 1983		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No	7,452,872	⤷ Start Trial				⤷ Start Trial
>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 Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-001	Dec 30, 1988	4,166,182	⤷ Start Trial
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-001	Approved Prior to Jan 1, 1982	4,316,897	⤷ Start Trial
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	4,247,547	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Tablets	200 mg	➤ Subscribe	2007-03-28
➤ Subscribe	Tablets	1.1 g	➤ Subscribe	2013-11-05
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2007-01-08
➤ Subscribe	Extended-release Tablets	300 mg	➤ Subscribe	2007-09-25

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	122008000041	Germany	⤷ Start Trial	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1539166	13C0062	France	⤷ Start Trial	PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
0526708	C300097	Netherlands	⤷ Start Trial	PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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