Last Updated: September 28, 2026

Vale Company Profile

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What is the competitive landscape for VALE

VALE has seventy approved drugs.

There are six US patents protecting VALE drugs.

Summary for Vale

US Patents:	6
Tradenames:	56
Ingredients:	45
NDAs:	70
Patent Litigation for Vale:	See patent lawsuits for Vale

Drugs and US Patents for Vale

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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	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090071-002	Apr 15, 2011		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharm Intl	BENDOPA	levodopa	CAPSULE;ORAL	016948-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharm Intl	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080592-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharms	MINITRAN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089771-001	Aug 30, 1996		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharm Intl	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084563-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharms North	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090071-001	Apr 15, 2011		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Valeant Pharm Intl	PREDNISONE	prednisone	TABLET;ORAL	080237-001	Approved Prior to Jan 1, 1982		DISCN	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

Expired US Patents for Vale

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-002	Approved Prior to Jan 1, 1982	4,316,897	⤷ Start Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	4,603,146	⤷ Start Trial
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,603,146	⤷ Start Trial
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	7,625,884	⤷ Start Trial
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	7,452,872	⤷ Start Trial
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-003	Dec 30, 1988	4,166,182	⤷ Start Trial
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982	3,729,568	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for VALE drugs

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

International Patents for Vale Drugs

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007025146	⤷ Start Trial
Israel	189104	⤷ Start Trial
Japan	2013032395	⤷ Start Trial
European Patent Office	2529729	⤷ Start Trial
New Zealand	603744	⤷ Start Trial
China	103948609	⤷ Start Trial
China	105267226	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Vale Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C01304992/01	Switzerland	⤷ Start Trial	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	2013C/060	Belgium	⤷ Start Trial	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
3209302	23C1035	France	⤷ Start Trial	PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; NAT. REGISTRATION NO/DATE: 34009 302 790 8 3 20230901; FIRST REGISTRATION: AT - 141371 20220826
1304992	PA2013025,C1304992	Lithuania	⤷ Start Trial	PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1539166	2013C/064	Belgium	⤷ Start Trial	PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
0591275	SPC/GB05/030	United Kingdom	⤷ Start 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
1458369	C01458369/01	Switzerland	⤷ Start Trial	PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Here is a list of applicants with similar names.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.