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Last Updated: November 13, 2024

AMLODIPINE BESYLATE Drug Patent Profile


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Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?

Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in sixty-nine NDAs.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

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Drug patent expirations by year for AMLODIPINE BESYLATE
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Drug Sales Revenue Trends for AMLODIPINE BESYLATE

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Recent Clinical Trials for AMLODIPINE BESYLATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Overseas Pharmaceuticals, Ltd.Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,LtdPhase 1
Northwestern UniversityPhase 4

See all AMLODIPINE BESYLATE clinical trials

US Patents and Regulatory Information for AMLODIPINE BESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Puracap Pharm AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078131-001 Sep 4, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-003 Mar 28, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 076846-003 Jun 28, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-003 Dec 19, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077262-002 Jul 9, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078552-002 Apr 8, 2009 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-001 Sep 27, 2007 ⤷  Sign Up ⤷  Sign Up
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-003 Sep 27, 2007 ⤷  Sign Up ⤷  Sign Up
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-002 Sep 27, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMLODIPINE BESYLATE

See the table below for patents covering AMLODIPINE BESYLATE around the world.

Country Patent Number Title Estimated Expiration
Australia 2002343257 ⤷  Sign Up
European Patent Office 1448197 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03043635 ⤷  Sign Up
Norway 20042539 ⤷  Sign Up
Argentina 037565 FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0443983 C00443983/03 Switzerland ⤷  Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785 C300486 Netherlands ⤷  Sign Up 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
0443983 2007C/043 Belgium ⤷  Sign Up PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1003503 05C0048 France ⤷  Sign Up 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
0502314 SPC/GB11/010 United Kingdom ⤷  Sign Up PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
1507558 C300528 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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