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Last Updated: July 13, 2024


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Which patents cover Propranolol Hydrochloride, and what generic alternatives are available?

Propranolol Hydrochloride is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Pai Holdings Pharm, Ani Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Endo Operations, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Purepac Pharm, Roxane, Sandoz, Schering, Strides Pharma, Superpharm, Teva, Warner Chilcott, Watson Labs, Watson Labs Teva, and Rising. and is included in one hundred and thirty-eight NDAs.

The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

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Drug patent expirations by year for PROPRANOLOL HYDROCHLORIDE

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

AIDS Malignancy ConsortiumPhase 2
Sir Run Run Shaw HospitalN/A
Unity Health TorontoN/A


Medical Subject Heading (MeSH) Categories for PROPRANOLOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PROPRANOLOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PROPRANOLOL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HEMANGEOL Oral Solution propranolol hydrochloride 4.28 mg/mL 205410 1 2022-07-21

US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070221-001 Apr 14, 1986 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070213-002 Nov 19, 1985 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Farmaceutica PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride INJECTABLE;INJECTION 077760-001 Jan 31, 2008 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078311-004 Mar 6, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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