Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
McKinsey
Merck
Mallinckrodt
Moodys

Last Updated: October 15, 2019

DrugPatentWatch Database Preview

Ranitidine hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for ranitidine hydrochloride and what is the scope of patent protection?

Ranitidine hydrochloride is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Appco Pharma Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Sandoz, Teva, Glaxosmithkline, Glaxo Grp Ltd, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Teligent, Actavis Mid Atlantic, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Torrent, Wockhardt, Sanofi Us, Acic Pharms, Amneal Pharms Ny, Ani Pharms Inc, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules India Ltd, Heritage Pharma, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Unique Pharm Labs, Vkt Pharma Pvt Ltd, Watson Labs, and Wockhardt Ltd, and is included in eighty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-three drug master file entries for ranitidine hydrochloride. One hundred and thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for ranitidine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
B.P. Koirala Institute of Health SciencesPhase 4
Ain Shams UniversityN/A
University of Sao Paulo General HospitalN/A

See all ranitidine hydrochloride clinical trials

Recent Litigation for ranitidine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22
Boehringer Ingelheim Pharmaceuticals Inc. v. Apotex Inc.2008-01-31
AstraZeneca Pharmaceuticals LP v. Apotex Inc.2007-12-11

See all ranitidine hydrochloride litigation

Generic filers with tentative approvals for RANITIDINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  See Pricing  See PricingEQ 300MG BASETABLET;ORAL
  See Pricing  See PricingEQ 150MG BASETABLET;ORAL
  See Pricing  See PricingEQ 25MG BASE/MLINJECTABLE;INJECTION

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 ranitidine hydrochloride
Synonyms for ranitidine hydrochloride
({5-[(2-{[(1Z)-1-(methylamino)-2-nitrovinyl]amino}ethylthio)methyl](2-furyl)}m ethyl)dimethylamine, chloride
(E)-1-N'-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine hydrochloride
(E)-N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-N'-methyl-2-nitroethene-1,1-diamine hydrochloride
(E)-N1'-[2-[[5-[(dimethylamino)methyl]-2-furanyl]methylthio]ethyl]-N1-methyl-2-nitroethene-1,1-diamine hydrochloride
(E)-N1'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-N1-methyl-2-nitro-ethene-1,1-diamine hydrochloride
(Z)-1-N'-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine hydrochloride
(Z)-N-(2-((5-((dimethylamino)methyl)furan-2-yl)methylthio)ethyl)-N-methyl-2-nitroethene-1,1-diamine hydrochloride
[(Dimethylamino)methyl]furfuryl]thio]ethyl]-N'-methyl-2-nitrovinylidenediamine monohydrochloride
[(E)-1-({2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}amino)-2-nitroethenyl](methyl)amine hydrochloride
1-N'-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine hydrochloride
1-N'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine;hydrochloride
1,1-Ethenediamine, N-(2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-nitro-, hydrochloride
1,1-Ethenediamine, N-(2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-nitro-, monohydrochloride
357N593
66357-35-5 (Parent)
66357-59-3
70956-04-6
71130-06-8
A830929
A835435
AB0013085
AB02807
AB1004865
AB2000300
AC-12743
AC1L2J0C
AC1MHVLK
AC1O7FV4
AC1Q38JI
ACT02689
AH 19065
AH 19065;Zantac
AH-19065
AH19065
AKOS015895250
AKOS015950825
AKOS025147306
AKOS030228564
Alquen
Alter-H2
Alvidina
Apo-Ranitidin
ARONIS24523
Artomil
Azantac
Azuranit
BBC/690
BCP13738
BCP28420
BIM-0051043.0001
BK76465IHM
C13H22N4O3S.HCl
CCG-212946
CCG-220201
CCRIS 5268
CHEBI:8777
CHEMBL1092473
CHEMBL1330865
CHEMBL2110372
Coralen [inj.]
CPD000653467
CS-2293
D00673
Digestosan
DTXSID0052835
EINECS 266-333-0
EINECS 275-207-4
Epitope ID:127516
Ergan
Esofex
EU-0101073
Fendibina
Gastrial
Gastridina
Gastrolav
GGWBHVILAJZWKJ-KJEVSKRMSA-N
GGWBHVILAJZWKJ-UHFFFAOYSA-N
H508
HMS1568J03
HY-B0281A
I06-0246
I06-2377
J10380
KB-277588
KM1010
KS-00000XKU
Kuracid
Label
Lake
Logat
LP01073
LS-67646
MCULE-8853752958
MFCD00069339
Mideran
MLS000069385
MLS001146938
MLS001333197
MLS001333198
MLS002153383
MLS002207038
MLS002548856
MolPort-003-959-435
MolPort-003-987-168
MolPort-028-751-168
N-(2-(((5-((Dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-nitro-1,1-ethenediamine, hydrochloride
N-(2-((5-((Dimethylamino)methyl)furfuryl)thio)ethyl)-N'-methyl-2-nitrovinylidenediamine hydrochloride
N-(2-((5-((Dimethylamino)methyl)furfuryl)thio)ethyl)-N'-methyl-2-nitrovinylidenediamine monohydrochloride
N-[2-[[[5-(dimethylamino)methyl-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine Hydrochloride
N-[2-[[[5-[(Dimethylamino)methyl]- 2-furanyl]methyl]thio]-ethyl]-N - methyl-2-nitro-1,1-ethenediamine
N-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-N'-methyl-2-nitroethene-1,1-diamine hydrochloride
N-[2-[[5-[(dimethylamino)methyl]furfuryl]thio]ethyl]-N'-methyl-2-nitrovinylidenediamine hydrochloride
N-[2-[5-[(Dimethylamino)methyl]furfurylthio]ethyl]-N'-methyl-2-Nitro-1,1-ethenediamine Hydrochloride
n-{2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}-n'-methyl-2-nitroethene-1,1-diamine hydrochloride(1:1)
NC00479
NCGC00094351-01
NCGC00261758-01
Neugal
Noctone
Noktome
Normon
Novo-Radinine
Nu-Ranit
Opera_ID_624
Pep-Rani
Prestwick_635
Q-201658
Quadrin
Quantor [inj.]
R-101
R0073
Radin
RAN
Ran H2
Ran Lich
Rani 2
Rani AbZ
Rani-BASF
Rani-nerton
Rani-Puren
Rani-Q
Rani-Sanorania
Raniben
Raniberl
Raniberta
Ranibeta
Ranibloc
ranic
Ranicux
Ranidil
Ranidin
Ranidura
Ranifur
Ranifur [inj.]
Ranigasan
Ranigast
Ranigen
Ranilonga
Ranimerck
Ranisan
Ranitab
Ranitic
Ranitidin
Ranitidin 1A Pharma
Ranitidin AL
Ranitidin Arcana
Ranitidin Atid
Ranitidin AWD
Ranitidin Basics
Ranitidin Duncan
Ranitidin Dyna
Ranitidin Helvepharm
Ranitidin Heumann
Ranitidin Hexal
Ranitidin Merck
Ranitidin Millet
Ranitidin NM
Ranitidin Normon
Ranitidin PB
Ranitidin Stada
Ranitidin von ct
Ranitidin-Cophar
Ranitidin-Isis
Ranitidin-ratiopharm
Ranitidina predilu Grif
Ranitidina Tamarang
Ranitidine (hydrochloride)
Ranitidine (Zantac)
Ranitidine for impurity A identification, EuropePharmacopoeia (EP) Reference Standard
Ranitidine for system suitability, European Pharmacopoeia (EP) Reference Standard
Ranitidine HCL
Ranitidine hydrochloride (JP17/USP)
Ranitidine Hydrochloride [USP:JAN]
Ranitidine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Ranitidine hydrochloride, British Pharmacopoeia (BP) Reference Standard
Ranitidine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Ranitidine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Ranitidine hydrochloride, solid
Ranitidine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Ranitidine Hydrochloride,(S)
Ranitin
Ranitine
Ranobel
Ranuber
Regalil
Renatac
Rozon
Rubiulcer
s1801
SAM002264645
Santanol
SC-19601
SCHEMBL33298
SCHEMBL33299
Serviradine
SMR000058545
SMR000653467
SR-01000000016
SR-01000000016-2
SR-01000000016-5
SR-01000075288
SR-01000075288-2
ST2419752
ST50827123
SW196800-3
Tanidina
TL8005002
Toriol
Tox21_501073
Trigger
Trigger [Drug]
Ulcecur
Ulcirex
Ulcodin
Ulcolind Rani
Ulsaven
UNII-BK76465IHM
Viserul
W-104534
Zandid
ZANTAC
Zantac (TN)
Zantac 150
Zantac 25
ZANTAC 300
Zantac 75
Zantac efferdose
Zantac In Plastic Container
Zantarac
ZX-AS004891

US Patents and Regulatory Information for ranitidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 201745-001 Feb 29, 2012 OTC No No   See Pricing   See Pricing   See Pricing
Amneal Pharms RANITIDINE HYDROCHLORIDE ranitidine hydrochloride SYRUP;ORAL 078312-001 Sep 2, 2008 AA RX No No   See Pricing   See Pricing   See Pricing
Aurobindo Pharma Ltd RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 207579-001 Nov 13, 2017 OTC No No   See Pricing   See Pricing   See 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 ranitidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 018703-001 Jun 9, 1983   See Pricing   See Pricing
Glaxosmithkline ZANTAC 300 ranitidine hydrochloride CAPSULE;ORAL 020095-002 Mar 8, 1994   See Pricing   See Pricing
Glaxo Grp Ltd ZANTAC 300 ranitidine hydrochloride TABLET;ORAL 018703-002 Dec 9, 1985   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Express Scripts
Dow
Harvard Business School
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.