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Last Updated: January 25, 2020

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AMLODIPINE BESYLATE Drug Profile

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Which patents cover Amlodipine Besylate, and what generic alternatives are available?

Amlodipine Besylate is a drug 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, Dr Reddys, Zydus Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in sixty-nine NDAs. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

US ANDA Litigation and Generic Entry Outlook for Amlodipine Besylate

Amlodipine Besylate was eligible for patent challenges on December 31, 1968.

Annual sales in 2017 were $69mm indicating the motivation for generic entry (peak sales were $984mm in 2009).

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

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

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
Sovereign Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 204900-001 Jul 23, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-003 Mar 28, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 203245-003 Oct 21, 2013 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

Premature patent expiration for: AMLODIPINE BESYLATE

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
  Start Trial AMLODIPINE BESYLATE   Start Trial

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 SPC/GB11/010 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon
McKinsey
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