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Last Updated: November 17, 2019

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PHENYLEPHRINE HYDROCHLORIDE Drug Profile

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Which patents cover Phenylephrine Hydrochloride, and when can generic versions of Phenylephrine Hydrochloride launch?

Phenylephrine Hydrochloride is a drug marketed by Akorn Inc, Paragon Bioteck, Amneal Pharms Co, Fresenius Kabi Usa, Meitheal, Par Sterile Products, Sandoz Inc, West Ward Pharm Corp, Hi Tech, and Vintage. and is included in thirteen NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

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

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

SponsorPhase
Helse FonnaPhase 4
Carilion ClinicPhase 2
Provepharm Life SolutionsPhase 2

See all PHENYLEPHRINE HYDROCHLORIDE clinical trials

Recent Litigation for PHENYLEPHRINE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.2017-01-17

See all PHENYLEPHRINE HYDROCHLORIDE litigation

PTAB Litigation
PetitionerDate
Altaire Pharmaceuticals, Inc.2015-05-11

See all PHENYLEPHRINE HYDROCHLORIDE litigation

Pharmacology for PHENYLEPHRINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for PHENYLEPHRINE HYDROCHLORIDE
Synonyms for PHENYLEPHRINE HYDROCHLORIDE
(-)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol, hydroc hloride
(-)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol, hydrochloride
(-)-alpha-Hydroxy-beta-(methylamino)ethyl-alpha-(3-hydroxybenzene) hydrochloride
(-)-m-Hydroxy-alpha-((methylamino)methyl)benzyl alcohol hydrochloride
(-)-Phenylephrine hydrochloride
(R)-(-)-1-(3-Hydroxyphenyl)-2-methylaminoethanol hydrochloride
(R)-(-)-3-Hydroxy-alpha-(methylaminomethyl)benzyl alcohol hydrochloride
(R)-(-)-Phenylephrine (hydrochloride)
(R)-(-)-Phenylephrine hydrochloride
(R)-(-)-Phenylephrine hydrochloride, analytical standard
(R)-(-)-Phenylephrine hydrochloride, powder
(R)-(-)-Phenylephrine hydrochloride, tested according to Ph.Eur.
(R)-3-(1-Hydroxy-2-(methylamino)ethyl)phenol hydrochloride
(R)-3-hydroxy-a-[(methylamino)methyl]-benzenemethanol hydrochloride
(R)-3-Hydroxy-alpha-((methylamino)methyl)benzenemethanol hydrochloride
(R)-Phenylephrine hydrochloride
04JA59TNSJ
1-m-Hydroxy-alpha-(methylaminomethyl)benzyl alcohol hydrochloride
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol hydrochloride
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol;hydrochloride
3-Hydroxy-alpha-(methylaminomethyl)benzyl alcohol hydrochloride
50741-76-9
59-42-7 (Parent)
61-76-7
644-22-4
827-62-3
AB2000665
AC1NR4GJ
Adrianol
Afrin 4 Hour Nasal Spray
AKOS022190146
Alcon Efrin
Alcon-efrin
Almefrin
BCP0726000237
BCP23410
Benzedrex Nasal Spray, Regular
Benzenemethanol, 3-hydroxy-a-[(methylamino)methyl]-, hydrochloride,(aR)-
Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, hydrochloride (1:1), (alphaR)-
Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, hydrochloride (R)-
Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, hydrochloride, (-)-
Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, hydrochloride, (alphaR)-
Benzyl alcohol, m-hydroxy-alpha-((methylamino)methyl)-, hydrochloride, (-)-
Biomydrin
C9H13NO2.HCl
CAS-61-76-7
CCG-39113
CCRIS 219
CHEBI:8094
CHEMBL1200339
Consdrin
Consdrin hydrochloride
CS-2585
D-(-)-Phenylephrine hydrochloride
D00511
DSSTox_CID_1142
DSSTox_GSID_21142
DSSTox_RID_75972
DTXSID3021142
EC 200-517-3
Efricel
EINECS 200-517-3
Emagrin
EU-0100920
Fenilfar
Fenox
GL9617
Histabid
HMS1920H08
HY-B0471
Idrianol
Isophrin hydrochloride
l-1-(m-Hydroxyphenyl)-2-methyl-aminoethanol hydrochloride
L-Pheny lephrine Hydrochloride
L-PHENYLEPHRINE HYDROCHLORIDE
L(-)-Phenylephrine hydrochloride
L(-)-Phenylephrine hydrochloride, 99%
Levophenylephrine hydrochloride
Lexatol
LP00920
LS-1454
m-Methylaminoethanolphenol hydrochloride
meta-Sympatol
meta-Synephrine hydrochloride
Metaoxedrine chloride
Metaoxedrine hydrochloride
MFCD00012605
MLS000069696
MLS006012005
MolPort-003-666-260
Mydfrin
NCGC00024257-04
NCGC00024257-08
NCGC00094231-01
NCGC00256496-01
NCGC00258813-01
NCGC00261605-01
NCI-C55641
Neo-Synephrine
Neo-Synephrine (TN)
Neo-Synesin 1
Neooxedrine chloride
Neophryn
Neosympatol
Neosynephrine hydrochloride
neosynephrine hydrocholride
Nostril
NSC-757273
NSC757273
OCYSGIYOVXAGKQ-FVGYRXGTSA-N
Oftalfrine
OP-Isophrin
Op-Isophrin-Z
Opera_ID_1786
P 6126
P0398
Pharmakon1600-01500483
Phenistan
Phenylephrine HCl
Phenylephrine hydrochloride (JP17/USP)
Phenylephrine hydrochloride [USAN:JAN]
Phenylephrine hydrochloride [USP:JAN]
Phenylephrine hydrochloride for peak identification, European Pharmacopoeia (EP) Reference Standard
Phenylephrine hydrochloride, British Pharmacopoeia (BP) Reference Standard
Phenylephrine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Phenylephrine hydrochloride, l-
Phenylephrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Phenylephrine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Phenylephrine hydrochloride,(S)
Phenylephrine.HCl
Prefrin
Prefrin Liquifilm
PubChem23988
Pyristan
Q-201561
R-(-)-m-Synephrine hydrochloride
R-(-)-Phenylephrine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Relief
Rhinall
s2569
SCHEMBL24654
SMR000058497
SPECTRUM1500483
SR-01000075286
SR-01000075286-1
ST24035423
Stanephrin
Sucraphen
Sudafed PE
SW219446-1
Synasal
Synethenate
Tox21_110897
Tox21_110897_1
Tox21_201261
Tox21_302846
Tox21_500920
UNII-04JA59TNSJ
UNII-O2VT86KV7E component OCYSGIYOVXAGKQ-FVGYRXGTSA-N
Vasosulf
Vazculep
Vicks Sinex Nasal Spray
Vicks Sinex Vapospray
VU0239753-6

US Patents and Regulatory Information for PHENYLEPHRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn Inc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 207926-001 Jan 15, 2015 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Sandoz Inc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 208905-002 Jan 31, 2019 AP1 RX No No   Start Trial   Start Trial   Start Trial
Vintage PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040654-001 Dec 7, 2006 AA RX No Yes   Start Trial   Start Trial   Start Trial
Amneal Pharms Co PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 211078-002 Jul 19, 2018 AP1 RX No No   Start Trial   Start Trial   Start Trial
Paragon Bioteck PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510-002 Mar 21, 2013 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Meitheal PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210333-001 Apr 27, 2018 AP1 RX 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

Supplementary Protection Certificates for PHENYLEPHRINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 92923 Luxembourg   Start Trial PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313 2015/071 Ireland   Start Trial PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 15C0090 France   Start Trial PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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