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Last Updated: June 29, 2022

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, Apotex, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, 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, Dr Reddys, Zydus Pharms, Pharmacia, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Teva Pharms, Watson Labs Inc, Novartis, Purple Biotech, 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 one hundred NDAs. There are eleven 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 twenty-seven drug master file entries for amlodipine besylate. Fifty-two 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
National Heart, Lung, and Blood Institute (NHLBI)Phase 4
American Society for TransplantationPhase 4
Northwestern UniversityPhase 4

See all amlodipine besylate clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 10MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 5MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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
Par Pharm Inc OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206137-002 Oct 26, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Torrent AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 202933-004 Nov 25, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Polygen Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 207821-003 Jul 11, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sciegen Pharms Inc AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209010-002 Dec 3, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 019787-002 Jul 31, 1992 See Plans and Pricing See Plans and Pricing
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 See Plans and Pricing See Plans and Pricing
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 See Plans and Pricing See Plans and Pricing
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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
1003503 05C0048 France See Plans and Pricing 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
0443983 C00443983/03 Switzerland See Plans and Pricing PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785 CA 2011 00026 Denmark See Plans and Pricing PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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