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Last Updated: May 18, 2021

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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, Paragon Bioteck, Eton Pharms, Accord Hlthcare, Amneal, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz Inc, Exela Pharma, Ani Pharms, Pharm Assoc, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Wockhardt, and Allergan, and is included in twenty-nine 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. Eighteen suppliers are listed for this compound.

Recent Clinical Trials for phenylephrine hydrochloride

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

SponsorPhase
Rabin Medical CenterN/A
Laval UniversityPhase 3
CHU de Quebec-Universite LavalPhase 3

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
Aurobindo Pharma Ltd PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210697-001 Nov 13, 2020 AP1 RX No No   Get Started Free   Get Started Free   Get Started Free
Ani Pharms PHENERGAN VC phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 008604-003 Apr 2, 1984 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Par Sterile Products PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210025-002 Dec 21, 2018 AP1 RX No No   Get Started Free   Get Started Free   Get Started Free
Cenci PROMETHAZINE VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088815-001 Nov 22, 1985 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Hikma PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 203826-003 Jun 19, 2019 AP2 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free 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   Get Started Free 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   Get Started Free 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

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

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Dow
Colorcon
Express Scripts
Merck

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