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Last Updated: December 6, 2019

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Metoclopramide hydrochloride - Generic Drug Details

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

Metoclopramide hydrochloride is the generic ingredient in nine branded drugs marketed by Roxane, Emcure Pharms Ltd, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, West-ward Pharms Int, Actavis Mid Atlantic, Ani Pharms, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Teva, Vistapharm, Wockhardt Bio Ag, Robins Ah, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Par Pharm Inc, Sandoz, Schering, Sun Pharm Industries, Superpharm, Usl Pharma, Vintage Pharms, Watson Labs, and Yaopharma Co Ltd, and is included in sixty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for metoclopramide hydrochloride. Thirty-six suppliers are listed for this compound.

Recent Clinical Trials for metoclopramide hydrochloride

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

SponsorPhase
Mansoura UniversityN/A
Wafaa HamzaN/A
Assiut UniversityN/A

See all metoclopramide hydrochloride clinical trials

Recent Litigation for metoclopramide hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
CIMA Labs Inc. v. Barr Laboratories Inc.2008-08-21
Plaintiff(s) v. Defendant(s)2008-01-31

See all metoclopramide hydrochloride litigation

Pharmacology for metoclopramide hydrochloride
Medical Subject Heading (MeSH) Categories for metoclopramide hydrochloride
Synonyms for metoclopramide hydrochloride
(4-amino-5-chloro-2-methoxyphenyl)-N-[2-(diethylamino)ethyl]carboxamide, chlor ide
2542AH
364-62-5 (Parent)
4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide hydrochloride
4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide monohydrochloride
4-Amino-5-Chloro-N-(2-(Diethylamino)Ethyl)-N-Anisamide
4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-o-anisamide hydrochloride
4-amino-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide hydrochloride
4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy-benzamide hydrochloride
4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide;hydrochloride
4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-o-anisamide hydrochloride
49625-23-2
7232-21-5
7B1QZY5SWZ
AB1009373
AC1L2MT3
AC1Q3LU2
AHR-3070-C
AKOS015889947
AN-16617
AN-40630
API0003351
API0006827
AX8140039
BCP28471
Benzamide, 4-amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxy-, monohydrochloride
Benzamide, 4-amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxy-, monohydrochloride (9CI)
Benzamide, 4-amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxy-, monohydrochloride, monohydrate
Benzamide, 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy-, hydrochloride (1:1)
BG0253
C14H22ClN3O2.ClH
C14H22ClN3O2.HCl
CCG-212697
CCRIS 7142
Cerucal
CHEMBL1256771
CPD000058471
CTK8G1096
EINECS 230-634-5
EU-0100762
FT-0657870
FT-0672375
H780
HMS1568J19
HMS1920N15
HS-0006
I01-4517
J10269
KB-240082
KB-304048
KS-000018AM
LP00762
LS-175536
LS-20040
M 0763
Maxolon
MCULE-8548227068
METOCLOPRAMIDE HCL
Metoclopramide Hydrochloride (anhydrous)
Metoclopramide hydrochloride [USAN:JAN]
Metoclopramide hydrochloride anhydrous
Metoclopramide hydrochloride, solid
Metoclopramide Intensol
Metoclopramide monohydrochloride
Metoclopramide monohydrochloride monohydrate
Metozolv
Metozolv ODT
MFCD00058011
MFCD00150634
MLS000069667
MLS001074186
MLS002222202
MolPort-003-666-233
NC00519
NCGC00094102-01
NCGC00094102-02
NCGC00094102-03
NCGC00094102-04
NCGC00094102-05
NCGC00261447-01
NSC 354467
NSC-354467
NSC-757117
NSC354467
NSC757117
o-Anisamide, 4-amino-5-chloro-N-(2-(diethylamino)ethyl)-, monohydrochloride
o-Anisamide, monohydrochloride
Opera_ID_1671
Paspertin
Pharmakon1600-01500410
Prestwick_332
Primperan (tablet)
Reglan
Reglan ODT
Rimetin
S4289
SAM002554911
SBB058161
SCHEMBL205200
SMR000058471
SPECTRUM1500410
SR-01000000165
SR-01000000165-2
SR-01000000165-7
ST24028881
ST51015042
SW196611-3
Tox21_500762
UNII-7B1QZY5SWZ
VU0239518-5
WLN: 2N2&2MVR DZ CG FO1 &GH
Paragraph IV (Patent) Challenges for METOCLOPRAMIDE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
METOZOLV ODT TABLET, ORALLY DISINTEGRATING;ORAL metoclopramide hydrochloride 022246 2010-08-24
REGLAN INJECTABLE;INJECTION metoclopramide hydrochloride 017862

US Patents and Regulatory Information for metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 073135-001 Nov 27, 1991 AP RX No No   Start Trial   Start Trial   Start Trial
Smith And Nephew METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 070623-001 Mar 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070926-001 Jun 26, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191-001 Aug 15, 2014 RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 071250-002 Dec 28, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987 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 metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
West-ward Pharms Int REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005   Start Trial   Start Trial
Salix Pharms METOZOLV ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246-002 Sep 4, 2009   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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