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Last Updated: February 28, 2024

Amlodipine besylate - Generic Drug Details


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What are the generic drug sources for amlodipine besylate and what is the scope of patent protection?

Amlodipine besylate is the generic ingredient in nineteen branded drugs marketed by Cmp Dev Llc, 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, Viatris, Apotex, Dr Reddys, Zydus Pharms, Pharmacia, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Teva Pharms, Watson Labs Inc, Sandoz, Purple Biotech, Par Pharm Inc, Teva Pharms Usa, Torrent, Cosette, Lupin Ltd, Novartis, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Sciegen Pharms Inc, Adhera, Boehringer Ingelheim, Hetero Labs, and Novel Labs Inc, and is included in one hundred NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for amlodipine besylate. Forty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices 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
Guangzhou Health Start Pharmaceutical Techology Co.,LtdPhase 1
Overseas Pharmaceuticals, Ltd.Phase 1
American Society for TransplantationPhase 4

See all amlodipine besylate clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 10MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 5MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 2.5MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Aurobindo Pharma Ltd AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 202239-003 Sep 5, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209042-001 Aug 14, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genpharm AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077362-002 Jul 9, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 205199-007 Nov 18, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 205199-003 Nov 18, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-005 Mar 7, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 202553-001 Apr 29, 2013 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
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Synthon Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET, ORALLY DISINTEGRATING;ORAL 022026-001 Sep 27, 2007 ⤷  Try a Trial ⤷  Try a Trial
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ⤷  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
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ⤷  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

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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.