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Last Updated: April 10, 2020

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Phenylephrine hydrochloride - Generic Drug Details

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

Phenylephrine hydrochloride is the generic ingredient in ten branded drugs marketed by Akorn Inc, Paragon Bioteck, Eton Pharms, Amneal, Fresenius Kabi Usa, Meitheal, Par Sterile Products, Riconpharma Llc, Sandoz Inc, West Ward Pharm Corp, Avadel Legacy, Ani Pharms, Hi Tech, Vintage, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Wockhardt, and Allergan, and is included in twenty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenylephrine hydrochloride has one patent family member in one country.

There are twenty-one drug master file entries for phenylephrine hydrochloride. Twenty suppliers are listed for this compound.

Recent Clinical Trials for phenylephrine hydrochloride

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

SponsorPhase
Helse FonnaPhase 4
Yale UniversityEarly Phase 1
Kasr El Aini HospitalPhase 4

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
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 HCl
(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
61-76-7
AB2000665
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
Isopto Frin
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
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-hydrochloride
Phenylephrine.HCl
Prefrin
Prefrin Liquifilm
PubChem23988
Pyristan
Q-201561
Q27107758
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
URI
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
Fresenius Kabi Usa PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210666-001 Jan 30, 2019 AP1 RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms PHENERGAN VC phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 008604-003 Apr 2, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
G And W Labs Inc PROMETH VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088761-001 Nov 8, 1984 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

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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Dow
Colorcon
Express Scripts
Merck

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