Last Updated: May 20, 2026

PHENYLEPHRINE Drug Patent Profile

Name: PHENYLEPHRINE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Phenylephrine is a drug marketed by Alcon, Caplin, Gland, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Baxter Hlthcare Corp, Be Pharms, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hikma, Meitheal, Milla Pharms, Ph Health, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, Genus, and Dr Reddys Labs Sa. and is included in thirty-two NDAs. There are two patents protecting this drug.

The generic ingredient in PHENYLEPHRINE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phenylephrine

A generic version of PHENYLEPHRINE was approved as phenylephrine hydrochloride; promethazine hydrochloride by GENUS on December 7^th, 2006.

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Summary for PHENYLEPHRINE

US Patents:	0
Applicants:	23
NDAs:	32
Drug Prices:	Drug price information for PHENYLEPHRINE
DailyMed Link:	PHENYLEPHRINE at DailyMed

Drug patent expirations by year for PHENYLEPHRINE

US Patents and Regulatory Information for PHENYLEPHRINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hainan Poly	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	218412-003	Mar 14, 2024	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Eugia Pharma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	210697-002	Nov 13, 2020	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Meitheal	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	210333-001	Apr 27, 2018	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	208905-001	Jan 31, 2019	AP1	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mankind Pharma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	217069-001	Aug 30, 2022	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Meitheal	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	210333-002	Apr 27, 2018	AP1	RX	No	No	⤷ 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.