You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

AMLODIPINE BESYLATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Upsher Smith Labs, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, 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. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Drug patent expirations by year for AMLODIPINE BESYLATE
Drug Prices for AMLODIPINE BESYLATE

See drug prices for AMLODIPINE BESYLATE

Drug Sales Revenue Trends for AMLODIPINE BESYLATE

See drug sales revenues for AMLODIPINE BESYLATE

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-003 Mar 28, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078573-003 Sep 22, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-003 Dec 19, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077262-002 Jul 9, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078552-002 Apr 8, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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 ⤷  Try a Trial ⤷  Try a Trial
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-002 Sep 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-003 Sep 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
>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
Argentina 037565 FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS. ⤷  Try a Trial
Norway 20042539 ⤷  Try a Trial
Australia 2002343257 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03043635 ⤷  Try a Trial
European Patent Office 1448197 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 2012/018 Ireland ⤷  Try a Trial PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1003503 05C0048 France ⤷  Try a 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
1915993 C300625 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983 C300445 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1507558 12C0033 France ⤷  Try a 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: CH - 6167801 20110705
0503785 C300375 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.