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Last Updated: February 18, 2020

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AMLODIPINE BESYLATE - Generic Drug Details

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What are the generic sources for amlodipine besylate and what is the scope of freedom to operate?

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, Hebei Changshan, 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 Lake, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher Smith Labs, Watson Labs, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Pfizer, Dr Reddys, Zydus Pharms, 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 four patent family members in four countries.

There are fifty drug master file entries for amlodipine besylate. Fifty-five 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

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SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Conjupro BiotherapeuticsPhase 1
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 1

See all AMLODIPINE BESYLATE clinical trials

Recent Litigation for AMLODIPINE BESYLATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Edwards Lifesciences AG v. CoreValve, Inc.2014-04-14
Pfizer Inc. v. Ranbaxy Laboratories Limited2008-03-24
Plaintiff(s) v. Defendant(s)2008-01-31

See all AMLODIPINE BESYLATE litigation

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
Synonyms for AMLODIPINE BESYLATE
(R,S,)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate
111470-99-6
2-(2-Aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic Acid 3-Ethyl 5-Methyl Ester Benzenesulfona
2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic acid O3-ethyl ester O5-methyl ester; benzenesulfonic acid
2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate
2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzenesulfonate
2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine benzenesulfonate
3-Ethyl 5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate
3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate
3-Ethyl 5-Methyl 2-(2-Aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate
3,5-Pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (+-)-, monobenzenesulfonate
3,5-Pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl-5-methyl ester, monobenzenesulfonate
470A996
A802368
AB0012646
AB2000306
AC-079
AC1L1TCT
AC1Q6WSZ
AK122586
AKOS001260256
AKOS016340493
Amcard
Amdepin
Amdipin
Amlodin
Amlodipine (besylate)
Amlodipine benzenesulfonate
Amlodipine benzenesulphonate
Amlodipine besilate
Amlodipine besilate (JP17)
Amlodipine besylate (Norvasc)
Amlodipine besylate (USAN)
Amlodipine besylate [USAN:USP]
Amlodipine besylate [USAN]
Amlodipine besylate, >=98% (HPLC)
Amlodipine besylate, European Pharmacopoeia (EP) Reference Standard
Amlodipine besylate, Pharmaceutical Secondary Standard; Certified Reference Material
Amlodipine besylate, racemic mixture
Amlodipine besylate, United States Pharmacopeia (USP) Reference Standard
Amlodipine for peak identification, European Pharmacopoeia (EP) Reference Standard
amlodipine; benzenesulfonic acid
Amlogard
Amlopin
Amlosyn
AN-7254
Antacal
AOB5215
API0005435
Astudar
AX8246764
BCP21993
BCP9000059
benzenesulfonic acid; 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzenesulfonic acid; O3-ethyl O5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzenesulfonic acid; O3-ethyl O5-methyl 2-(2-azanylethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
C20H25ClN2O5.C6H6O3S
C26H31ClN2O8S
CA0135
Cardiorex
CAS-111470-99-6
CCG-39531
CHEBI:2669
CHEMBL1200402
CHEMBL3193637
CHEMBL3207778
Cordarene
CS-3988
D00615
DSSTox_CID_23909
DSSTox_GSID_43909
DSSTox_RID_80087
DTXSID2043909
F6170-0024
FT-0082675
FT-0622301
HMS2094E13
HMS2232D22
HMS2235B19
HMS3269B19
HMS3372O18
HMS3373F15
HSDB 7079
HY-B0317B
I06-0736
Istin
Istin;Norvasc;Norvasc
J10223
J10238
KB-295583
KBio2_001053
KBio2_003621
KBio2_006189
KBioSS_001053
KS-1029
LS-131175
MCULE-3638128556
MFCD00864687
MFCD00887594
MLS001361394
MolPort-001-759-081
Monopina
Myodura
NCGC00095835-01
NCGC00165957-04
Norlopin
Norvas
Norvasc (TN)
Norvask
NSC-758922
NSC758922
Pelmec
Pharmakon1600-01505202
Q-101934
Q-200627
r-amlodipine
s1813
SCHEMBL41282
SMR000875356
Spectrum_000573
SPECTRUM1505202
SR-05000001461-2
Stamlo
SW198880-2
Tensivask
Terloc
TL8000339
Tox21_111525
Tox21_113476
UK 48340-26
UK-48,340
UK-48,340-26
UK-48340-26
UK-4834026
VU0244594-3
ZPBWCRDSRKPIDG-UHFFFAOYSA-N
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
Mylan AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-010 Nov 29, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sovereign Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 204900-003 Jul 23, 2015 DISCN 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
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-001 Dec 19, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 207762-005 Jan 11, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Teva AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 076846-002 Jun 28, 2007 DISCN 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
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992   Start Trial   Start Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992   Start Trial   Start Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992   Start Trial   Start Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992   Start Trial   Start Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992   Start Trial   Start Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 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
0443983 C300445 Netherlands   Start Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0503785 C300375 Netherlands   Start 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
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
1003503 05C0048 France   Start 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
0503785 CA 2011 00026 Denmark   Start Trial 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
0678503 C300499 Netherlands   Start Trial PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
1507558 2012/018 Ireland   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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