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Last Updated: November 24, 2024

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 patent protection?

Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Lupin Ltd, Strides Pharma, Teva Pharms, Torrent, and Novartis, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXFORGE HCT Tablets amlodipine besylate; hydrochlorothiazide; valsartan 10 mg/12.5 mg/ 160 mg 022314 1 2009-10-22
EXFORGE HCT Tablets amlodipine besylate; hydrochlorothiazide; valsartan 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg 022314 1 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
Strides Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-003 Jun 1, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-003 Jun 3, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-002 Jun 1, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-005 Jun 1, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435-001 Sep 25, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-001 Dec 19, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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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. 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.