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 Pharms North	FENOFIBRATE	fenofibrate	TABLET;ORAL	090715-002	Apr 5, 2012	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Valeant	PHRENILIN	acetaminophen; butalbital	TABLET;ORAL	087811-001	Jun 19, 1985		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Pharm Intl	ANDROID-F	fluoxymesterone	TABLET;ORAL	087196-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Valeant Pharms North	MINITRAN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089772-001	Aug 30, 1996		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 Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	6,197,341	⤷ Try a Trial
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	3,906,108	⤷ Try a Trial
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005	6,254,887	⤷ Try a Trial
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	4,957,730	⤷ 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
Canada	2816276	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011137103	⤷ Try a Trial
South Korea	20140098863	⤷ Try a Trial
Japan	2009506067	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C300617	Netherlands	⤷ Try a Trial	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
1458369	122008000041	Germany	⤷ Try a Trial	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1539166	92323	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
0352076	SPC/GB01/005	United Kingdom	⤷ Try a Trial	PRODUCT NAME: VERTEPORFIN OPTIONALLY IN THE FORM OF A SALT THEREOF; REGISTERED: UK EU/1/00/140/001 20000727
>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.