Vale Company Profile

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VALE has eighty-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 forty-five 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 Pharm Intl	ELDECORT	hydrocortisone	CREAM;TOPICAL	084055-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Pharm Intl	8-MOP	methoxsalen	CAPSULE;ORAL	009048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Luxembourg	GRIFULVIN V	griseofulvin, microsize	SUSPENSION;ORAL	062483-001	Jan 26, 1984		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	AB1	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Valeant	PHRENILIN WITH CAFFEINE AND CODEINE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074911-001	Aug 22, 2001		DISCN	No	No		⤷ Try a Trial				⤷ Try a 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 Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005	7,074,430	⤷ Try a Trial
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-002	Dec 30, 1988	4,797,405	⤷ Try a Trial
Valeant Luxembourg	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,770,619	⤷ Try a Trial
Valeant Luxembourg	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,756,541	⤷ Try a Trial
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982	3,729,568	⤷ Try a Trial
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	3,729,568	⤷ Try a Trial
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	3,906,108	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2007-01-08
➤ Subscribe	Extended-release Tablets	300 mg	➤ Subscribe	2007-09-25
➤ Subscribe	Cream	0.5%	➤ Subscribe	2011-07-29
➤ Subscribe	Capsules	75 mg	➤ Subscribe	2011-06-06
➤ Subscribe	Extended-release Tablets	200 mg	➤ Subscribe	2007-03-28
➤ Subscribe	Tablets	1.1 g	➤ Subscribe	2013-11-05

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Country	Patent Number	Estimated Expiration
Japan	2010509326	⤷ Try a Trial
European Patent Office	2586427	⤷ Try a Trial
Brazil	PI0717859	⤷ Try a Trial
New Zealand	593132	⤷ Try a Trial
China	101247812	⤷ Try a Trial
Japan	2013525440	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011137103	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	2001/009	Ireland	⤷ Try a Trial	PRODUCT NAME: PANRETIN-ALITRETINOIN
0352076	1/2001	Austria	⤷ Try a Trial	PRODUCT NAME: VERTEPORFIN; REGISTRATION NO/DATE: EU/1/00/140/001 20000727
1304992	1390049-3	Sweden	⤷ Try a Trial	PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
0809498	SPC/GB10/012	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
1586316	122011100019	Germany	⤷ Try a Trial	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1304992	92401	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0591275	SPC/GB05/030	United Kingdom	⤷ Try a Trial	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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Here is a list of applicants with similar names.