You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Dow
Merck
AstraZeneca
Baxter

Last Updated: August 6, 2020

DrugPatentWatch Database Preview

Phenylephrine hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for phenylephrine hydrochloride

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

SponsorPhase
Helse FonnaPhase 4
University of Missouri-ColumbiaEarly Phase 1
Rajesh DesharN/A

See all phenylephrine hydrochloride clinical trials

Pharmacology for phenylephrine hydrochloride
Medical Subject Heading (MeSH) Categories for phenylephrine hydrochloride

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
Riconpharma Llc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 209967-001 Jan 16, 2020 AP1 RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210025-002 Dec 21, 2018 AP1 RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210666-002 Jan 30, 2019 AP1 RX No No   Start Trial   Start Trial   Start Trial
Hi Tech PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040675-001 Dec 23, 2014 AA 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Dow
Colorcon
Express Scripts
Merck

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 verification 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.