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Last Updated: September 25, 2022

PHENYLEPHRINE HYDROCHLORIDE Drug Patent 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, Paragon Bioteck, Accord Hlthcare, Amneal, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz Inc, and Pharm Assoc. and is included in twenty 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. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

Drug patent expirations by year for PHENYLEPHRINE HYDROCHLORIDE

US Patents and Regulatory Information for PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE is protected by one US patents.

Patents protecting PHENYLEPHRINE HYDROCHLORIDE

Methods and compositions of stable phenylephrine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DILATION OF THE PUPIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040675-001 Dec 23, 2014 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Provepharm Sas PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 211081-001 Jul 17, 2020 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Meitheal PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210333-002 Apr 27, 2018 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Provepharm Sas PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 211081-002 Jul 17, 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

International Patents for PHENYLEPHRINE HYDROCHLORIDE

See the table below for patents covering PHENYLEPHRINE HYDROCHLORIDE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2015073696 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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:

Dow
Mallinckrodt
Merck
Boehringer Ingelheim
Baxter
Colorcon

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. 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.