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Generated: November 20, 2018

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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 amlodipine besylate 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 Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine Lake, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Vivimed Global, Watson Labs, West-ward Pharms Int, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Pfizer, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Kitov Pharms Ltd, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, Daiichi Sankyo, Lupin Ltd, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Zydus Pharms Usa Inc, Marina Biotech, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety-five NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate. Eighty-one suppliers are listed for this compound. There are five tentative approvals for this compound.

Pharmacology for amlodipine besylate
Synonyms for amlodipine besylate
()-3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate monobenzenesulfonate
(+-)-AMLODIPINE; BENZENESULFONIC ACID
(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
3B1-000143
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; traceable to USP and PhEur
Amlodipine besylate, racemic mixture
Amlodipine besylate, United States Pharmacopeia (USP) Reference Standard
Amlodipine besylate?
Amlodipine for peak identification, European Pharmacopoeia (EP) Reference Standard
amlodipine; benzenesulfonic acid
Amlogard
Amlopin
Amlosyn
AN-7254
Antacal
Antihyperlipidemic, Forbes Medi-Tech
AOB5215
API0005435
Astudar
AX8246764
BCP9000059
benzenesulfonic acid 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
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
D0H7WA
DR003289
DSSTox_CID_23909
DSSTox_GSID_43909
DSSTox_RID_80087
DTXSID2043909
F6170-0024
FCP-3P1
FT-0082675
FT-0622301
HE313451
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
Norvask
NSC-758922
NSC758922
Pelmec
Pharmakon1600-01505202
Q-101934
Q-200627
r-amlodipine
s1813
SCHEMBL41282
SMR000875356
Spectrum_000573
SPECTRUM1505202
ST51052834
Stamlo
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
Tentative approvals for AMLODIPINE BESYLATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MG; 20MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up5MG; 20MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up5MG; 10MGCAPSULE; ORAL

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
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-004 Jun 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novel Labs Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202829-001 Mar 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm Inc OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206137-004 Oct 26, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ➤ Sign Up ➤ Sign Up
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for amlodipine besylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/010 United Kingdom ➤ Sign Up 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
C0033 France ➤ Sign Up PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
07C/043 Belgium ➤ Sign Up PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fuji
Dow
Farmers Insurance
Julphar
US Department of Justice
McKinsey
Harvard Business School
Cerilliant

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