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Generated: May 26, 2018

DrugPatentWatch Database Preview

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 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, 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, Vintage, Vivimed Global, Watson Labs, West-ward Pharms Int, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd. and is included in sixty-six 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. Ten suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Drug patent expirations by year for AMLODIPINE BESYLATE
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

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
Sun Pharm Inds Ltd AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077974-001 Jul 9, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-003 Jun 1, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vivimed Global AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077516-003 Jul 11, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 206367-001 Dec 10, 2015 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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Premature patent expiration for: AMLODIPINE BESYLATE

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Sign Up AMLODIPINE BESYLATE ➤ Sign Up

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Supplementary Protection Certificates for AMLODIPINE BESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00478 Netherlands ➤ Sign Up PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0625 Netherlands ➤ Sign Up 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
C0048 France ➤ Sign Up 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
McKesson
Cipla
US Army
Daiichi Sankyo
UBS
Boehringer Ingelheim
Fuji

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