Last Updated: August 3, 2026

Vale Company Profile


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Summary for Vale
International Patents:44
US Patents:6
Tradenames:56
Ingredients:45
NDAs:72
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 DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Valeant Pharm Intl LIBRELEASE chlordiazepoxide CAPSULE, EXTENDED RELEASE;ORAL 017813-001 Sep 12, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No 7,452,872 ⤷  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 PERMAX pergolide mesylate TABLET;ORAL 019385-001 Dec 30, 1988 4,166,182 ⤷  Start Trial
Valeant Pharm Intl LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 012249-001 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Start Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 4,247,547 ⤷  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

Supplementary Protection Certificates for Vale Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 122008000041 Germany ⤷  Start Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1539166 13C0062 France ⤷  Start Trial PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
0526708 C300097 Netherlands ⤷  Start Trial PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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