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Last Updated: December 6, 2019

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PROMETHAZINE HYDROCHLORIDE Drug Profile

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When do Promethazine Hydrochloride patents expire, and what generic alternatives are available?

Promethazine Hydrochloride is a drug marketed by Abbott, Akorn, Am Regent, Bedford Labs, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, X-gen Pharms, Able, Acp Nimble, Perrigo Israel, Taro, Watson Labs Inc, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Vintage, Whiteworth Town Plsn, Amneal Pharms Ny, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Quagen, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Hi-tech Pharma Co. and is included in eighty-seven NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Drug patent expirations by year for PROMETHAZINE HYDROCHLORIDE
Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE

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SponsorPhase
University of Alabama at BirminghamPhase 4
Joseph DibPhase 4
Hopital Psychiatrique De La CroixPhase 4

See all PROMETHAZINE HYDROCHLORIDE clinical trials

Pharmacology for PROMETHAZINE HYDROCHLORIDE
Drug ClassPhenothiazine
Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE
Synonyms for PROMETHAZINE HYDROCHLORIDE
(+-)-10-(2-(Dimethylamino)propyl)phenothiazine monohydrochloride
(+/-)-Promethazine Hydrochloride
(2-Dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine Hydrochloride
10-(2-(Dimethylamino)propyl)phenothiazine monohydrochloride
10-(2-Dimethylamino-1-propyl)phenothiazine hydrochloride
10-(2-Dimethylaminopropyl)phenothiazine hydrochloride
10-(3-dimethylaminoisoprop yl)phenothiazine hydrochloride
10-(3-Dimethylaminoisopropyl)phenothiazine hydrochloride
10-[2-(Dimethylamino)propyl]phenothiazine hydrochloride
10H-Phenothiazine-10-ethanamine, N,N,.alpha.-trimethyl-, hydrochloride (1:1)
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, hydrochloride (1:1)
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, monohydrochloride
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, monohydrochloride, (+-)-
10H-Phenothiazine-10-ethanamine,N,.alpha.-trimethyl-, monohydrochloride
16639-38-6
3277 R.P
3277 R.P.
58-33-3
88208-28-0
A831833
AB0013086
AC-12482
AC1L1LM3
AKOS016339657
Allerfen
AN-41751
Anergan 25
Anergan 50
API0003942
Atosil
AX8055660
BBC/878
Bonnox
CAS-58-33-3
CCG-207895
CCRIS 5873
CHEBI:8462
CHEMBL1200750
Closin
component of Mepergan
CPD000058379
CS-3543
CTK8G2592
D00480
DIMETHYL[1-(10H-PHENOTHIAZIN-10-YL)PROPAN-2-YL]AMINE HYDROCHLORIDE
Diprasine
Diprazin
Dorme
DSSTox_CID_1192
DSSTox_GSID_21192
DSSTox_RID_76002
DTXSID3021192
Duplamin
EINECS 200-375-2
EU-0100899
Eusedon Mono
F0138-3355
Farganesse
Fellozine
Fenergan
Frinova
FT-0631258
Ganphen
Goodnight
H509
Hibechin
Histantil
HL 8700
HMS1570B18
HMS1920L16
HY-B0781
J10089
Kinetosin
KS-0000129F
KS-1385
Lergigan
LP00899
LS-40
MCULE-6615710182
MFCD00012652
MLS000069398
MLS001074184
MLS002548850
MolPort-003-666-272
Mymethazine Fortis
N-(2-dimethylaminoprop-1-yl)phenothiazine hydrochloride
N-(2-Dimethylaminopropyl-1)phenothiazine hydrochloride
N-(2'-Dimethylamino-2-methylethyl)phenothiazine hydrochloride
N-(2'-Dimethylamino-2'-methyl)ethylphenothiazine hydrochloride
N-(2'-Dimethylamino-2'-methylaethyl)-phenothiazin hydrochlorid
N-(2'-dimethylamino-2'-methylethyl)phenothiazine hydrochlor ide
N-(2'-dimethylamino-2'-methylethyl)phenothiazine hydrochloride
N,N-dimethyl-1-(10-phenothiazinyl)-2-propanamine hydrochloride
N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine hydrochloride
N,N-dimethyl-1-phenothiazin-10-yl-propan-2-amine hydrochloride
N,N-dimethyl-1-phenothiazin-10-ylpropan-2-amine hydrochloride
N,N-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydrochloride
N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine monohydrochloride
NC00471
NCGC00089735-04
NCGC00094215-01
NCGC00094215-02
NCGC00094215-03
NCGC00094215-04
NCGC00094215-05
NCGC00256588-01
NCGC00259813-01
NCGC00261584-01
NSC 231688
NSC-231688
NSC-757301
NSC231688
NSC757301
Opera_ID_1745
P 4651
P2029
Pharmakon1600-01500510
Phenadoz
Phencen
Phenergan
Phenergan (TN)
Phenergan Fortis
Phenergan hydrochloride
PHENERGAN PLAIN
Phenothiazine, 10-(2-(dimethylamino)-propyl)-, hydrochloride
Phenothiazine, 10-(2-(dimethylamino)propyl)-, monohydrochloride
Phergan
Pipolfen
Pipolphen
Plletia
PMS Promethazine
prim ine
Primine
Promantine
Prome
Prometh Fortis
Prometh Plain
Promethazine (hydrochloride)
Promethazine chloride
Promethazine for peak identification, European Pharmacopoeia (EP) Reference Standard
Promethazine Hcl
Promethazine hydrochloride (JP17/USP)
PROMETHAZINE HYDROCHLORIDE (SEE ALSO PROMETHAZINE 60-87-7)
Promethazine hydrochloride [JAN]
Promethazine hydrochloride [USP:JAN]
Promethazine Hydrochloride 1.0 mg/ml in Dimethyl Sulfoxide (as free base)
Promethazine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Promethazine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Promethazine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Promethazine hydrochloride, VETRANAL(TM), analytical standard
Promethazine hydrochloride, vial of 25 mg, certified reference material
Promethazine Hydrochloride,(S)
Promethazine hydrochlorine
Promethazine monohydrochloride
Promethazine Plain
Promethazine.HCl
PromethazineHydrochloride
Promethegan (TN)
Promethiazin
Promethiazin [German]
Promine
Proneurin
Remsed
Romergan
RP 3389
s4293
SAM002264636
SC-19551
SCHEMBL41904
SMR000058379
Sominex
Soporil
SPECTRUM1500510
SR-01000002993
SR-01000002993-2
SR-01000002993-7
ST24048193
ST51015100
SW197234-3
Tox21_202264
Tox21_302878
Tox21_500899
TRA0003095
V GAN
Vallgerine
W-105399
WLN: T C666 BN ISJ B1Y1&N1&1 &GH
XXPDBLUZJRXNNZ-UHFFFAOYSA-N
Z1259273234
Zipan-25
ZIPAN-50

US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 091054-002 Aug 30, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083712-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Kv Pharm PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 085388-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Acp Nimble PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040428-001 Feb 5, 2002 AB RX No Yes   Start Trial   Start Trial   Start Trial
Sandoz PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084176-001 Approved Prior to Jan 1, 1982 AB RX No Yes   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

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