Last Updated: June 30, 2026

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Drug Patent Profile


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When do Phenylephrine Hydrochloride In 0.9% Sodium Chloride patents expire, and what generic alternatives are available?

Phenylephrine Hydrochloride In 0.9% Sodium Chloride is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Phenylephrine Hydrochloride In 0.9% Sodium Chloride

A generic version of PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE was approved as phenylephrine hydrochloride by HIKMA on December 20th, 2012.

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Summary for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
International Patents:2
US Patents:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is protected by one US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 216830-001 May 30, 2025 RX Yes Yes 12,564,561 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

See the table below for patents covering PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE around the world.

Country Patent Number Title Estimated Expiration
Argentina 124867 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2022172253 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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