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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Argus Health
Cerilliant
Colorcon
Boehringer Ingelheim
Cantor Fitzgerald
Baxter
Accenture

Generated: July 18, 2018

DrugPatentWatch Database Preview

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details

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What are the generic sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of amlodipine besylate; hydrochlorothiazide; valsartan 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 Pharms Ltd, 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. Ten suppliers are listed for this compound.
Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Pharmacology for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

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
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-002 Jun 3, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-004 Jun 3, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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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 022314-002 Apr 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
315 Luxembourg ➤ Try a Free Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
C0048 France ➤ Try a Free Trial PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
07C/043 Belgium ➤ Try a Free Trial PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983/03 Switzerland ➤ Try a Free Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Accenture
Julphar
Argus Health
Covington
Chinese Patent Office
Cerilliant
Farmers Insurance

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