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Last Updated: April 24, 2024

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 twelve branded drugs marketed by Alcon, Mankind Pharma, Paragon Bioteck, Dr Reddys Labs Sa, Hikma, Accord Hlthcare, Amneal, Avet Lifesciences, Be Pharms, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz, Exela Pharma, Ani Pharms, Pharm Assoc, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Xttrium Labs Inc, Allergan, and Eyenovia, and is included in thirty-five NDAs. There are six patents 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. Thirty-one suppliers are listed for this compound.

Recent Clinical Trials for phenylephrine hydrochloride

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

SponsorPhase
University of MiamiPhase 4
Abant Izzet Baysal UniversityPhase 4
Ciusss de L'Est de l'Île de MontréalN/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
Sagent Pharms Inc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 209967-002 Jan 16, 2020 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210666-002 Jan 30, 2019 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210696-001 Jan 7, 2021 AP2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 213237-001 Jul 1, 2020 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa BIORPHEN phenylephrine hydrochloride SOLUTION;INTRAVENOUS 212909-001 Oct 21, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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 92923 Luxembourg ⤷  Try a 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 ⤷  Try a 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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