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Last Updated: February 24, 2020

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Amlodipine besylate; hydrochlorothiazide; valsartan - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of freedom to operate?

Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Par Pharm, Teva Pharms, Torrent, and Novartis, and is included in six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; hydrochlorothiazide; valsartan has sixty-two patent family members in thirty-two countries.

There are fifty drug master file entries for amlodipine besylate; hydrochlorothiazide; valsartan. Six suppliers are listed for this compound.

Summary for amlodipine besylate; hydrochlorothiazide; valsartan
Recent Litigation for amlodipine besylate; hydrochlorothiazide; valsartan

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District Court Litigation
Case NameDate
NOVARTIS PHARMACEUTICALS CORPORATION v. LUPIN LTD.2012-07-20
Novartis Pharmaceuticals Corporation v. Lupin Ltd.2012-05-14
Walgreen CO v. Novartis Pharmaceuticals Corporation

See all amlodipine besylate; hydrochlorothiazide; valsartan litigation

Pharmacology for amlodipine besylate; hydrochlorothiazide; valsartan
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Tradename Dosage Ingredient NDA Submissiondate
EXFORGE HCT TABLET;ORAL amlodipine besylate; hydrochlorothiazide; valsartan 022314 2009-10-22
EXFORGE HCT TABLET;ORAL amlodipine besylate; hydrochlorothiazide; valsartan 022314 2009-09-14

US Patents and Regulatory Information for amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-005 Jun 1, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200797-005 Jun 3, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200797-001 Jun 3, 2015 AB RX No No   Start Trial   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 amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009   Start Trial   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009   Start Trial   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for amlodipine besylate; hydrochlorothiazide; valsartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 12C0033 France   Start Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
1915993 92315 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785 C300486 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Moodys
AstraZeneca
Baxter
McKesson

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