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Last Updated: August 9, 2020

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PHENYLEPHRINE HYDROCHLORIDE Drug Profile

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Which patents cover Phenylephrine Hydrochloride, and when can generic versions of Phenylephrine Hydrochloride launch?

Phenylephrine Hydrochloride is a drug marketed by Akorn Inc, Paragon Bioteck, Amneal, Fresenius Kabi Usa, Meitheal, Par Sterile Products, Riconpharma Llc, Sandoz Inc, West Ward Pharm Corp, Hi Tech, and Vintage. and is included in fourteen NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Phenylephrine Hydrochloride

Indicators of Generic Entry

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Drug patent expirations by year for PHENYLEPHRINE HYDROCHLORIDE
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
Akorn Inc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 207926-001 Jan 15, 2015 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Riconpharma Llc PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 209967-002 Jan 16, 2020 AP1 RX No No   Start Trial   Start Trial   Start Trial
West Ward Pharm Corp PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 203826-002 Jun 19, 2019 AP2 RX Yes Yes   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 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 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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