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Last Updated: September 25, 2022

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, Dr Reddys Labs Sa, Accord Hlthcare, Amneal, Caplin, Eugia Pharma, 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 twelve drug master file entries for phenylephrine hydrochloride. Twenty-one suppliers are listed for this compound.

Recent Clinical Trials for phenylephrine hydrochloride

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

SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
Mersin UniversityPhase 4
Medical University of ViennaPhase 4

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
Gland Pharma Ltd PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 211920-002 Jun 5, 2020 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 203826-001 Dec 20, 2012 AP2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 213237-003 Jul 1, 2020 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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 92923 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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
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Express Scripts
Merck

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