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	LIBRITABS	chlordiazepoxide	TABLET;ORAL	085482-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Vale	AMINOPHYLLINE	aminophylline	TABLET, DELAYED RELEASE;ORAL	084530-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharms Intl	CUPRIMINE	penicillamine	CAPSULE;ORAL	019853-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Valeant Pharms North	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	075269-001	Dec 4, 2000	AB1	RX	No	No		⤷ 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	019385-002	Dec 30, 1988	4,166,182	⤷ Start Trial
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	4,247,547	⤷ Start Trial
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	3,729,568	⤷ Start Trial
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-003	Dec 30, 1988	4,797,405	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Tablets	300 mg	➤ Subscribe	2007-09-25
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	C300043	Netherlands	⤷ Start Trial	PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
3209302	LUC00304	Luxembourg	⤷ Start Trial	PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; MARKETING AUTHORISATION NUMBER AND DATE: 141371, 20220826
3209302	301224	Netherlands	⤷ Start Trial	PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG128752 20221107; FIRST REGISTRATION: AT 141371 20220826
1304992	CR 2013 00053	Denmark	⤷ Start Trial	PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.