Vale Company Profile

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VALE has eighty-one 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-one 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	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Valeant Pharms North	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	075289-001	Sep 27, 2000	AB2	RX	No	No		⤷ Sign Up				⤷ Sign Up
Valeant Pharm Intl	PREDNISOLONE	prednisolone	TABLET;ORAL	080236-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Valeant Pharm Intl	BENDOPA	levodopa	CAPSULE;ORAL	016948-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ 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 Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,877,805	⤷ Sign Up
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005	7,074,430	⤷ Sign Up
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,423,041	⤷ Sign Up
Valeant Pharm Intl	LIBRELEASE	chlordiazepoxide	CAPSULE, EXTENDED RELEASE;ORAL	017813-001	Sep 12, 1983	4,316,897	⤷ Sign Up
>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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	CR 2015 00042	Denmark	⤷ Sign Up	PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
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
0137963	97C0042	Belgium	⤷ Sign Up	PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1304992	132013902214376	Italy	⤷ Sign Up	PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
>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.