Last Updated: November 8, 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

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 LEVO-DROMORAN levorphanol tartrate TABLET;ORAL 008720-001 Dec 19, 1991 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Valeant Pharms North SECONAL SODIUM secobarbital sodium CAPSULE;ORAL 086101-002 Oct 3, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial
Valeant Pharm Intl BENDOPA levodopa CAPSULE;ORAL 016948-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Valeant Intl RETIN-A tretinoin SWAB;TOPICAL 016921-002 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 012249-001 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Start Trial
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 4,423,041 ⤷  Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 6,254,887 ⤷  Start Trial
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-003 Dec 30, 1988 4,180,582 ⤷  Start Trial
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 RE36068 ⤷  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 100 mg ➤ Subscribe 2007-01-08
➤ 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

Supplementary Protection Certificates for Vale Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 2013/055 Ireland ⤷  Start Trial PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
0137963 97C0042 Belgium ⤷  Start Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
2488169 C202330042 Spain ⤷  Start Trial PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
1458369 C01458369/01 Switzerland ⤷  Start Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
0566709 C300152 Netherlands ⤷  Start Trial PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant 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.