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Last Updated: February 28, 2021

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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 eighteen branded drugs marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, 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, Yaopharma Co Ltd, Yiling, Zydus Pharms Usa, Upjohn, Dr Reddys, Zydus Pharms, Pharmacia, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Coeptis, Par Pharm Inc, Teva Pharms Usa, Torrent, Daiichi Sankyo, Lupin Ltd, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Sciegen Pharms Inc, Adhera, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety-nine NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate has five patent family members in five countries.

There are fifty drug master file entries for amlodipine besylate. Fifty-one 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
University of PennsylvaniaPhase 4
Shanghai Jiao Tong University School of MedicinePhase 4
Conjupro BiotherapeuticsPhase 1

See all amlodipine besylate clinical trials

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

Pharmacology for amlodipine besylate
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE
Tradename Dosage Ingredient NDA Submissiondate
NORVASC TABLET;ORAL amlodipine besylate 019787

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
Dr Reddys Labs Inc AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077183-002 Apr 15, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 207450-001 May 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078043-002 Jul 12, 2007 AB RX No No   Start Trial   Start Trial   Start 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
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992   Start Trial   Start Trial
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992   Start Trial   Start Trial
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for amlodipine besylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C300528 Netherlands   Start Trial 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
0503785 C300486 Netherlands   Start Trial 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
1915993 300625 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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