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Last Updated: July 16, 2020

DrugPatentWatch Database Preview

Propranolol hydrochloride - Generic Drug Details

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What are the generic drug sources for propranolol hydrochloride and what is the scope of patent protection?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms Inc, Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Roxane, Athenex Inc, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Pierre Fabre Derma, Hikma, Morton Grove, Wyeth Ayerst, Wyeth Pharms, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Par Pharm, Purepac Pharm, Sandoz, Schering, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Yaopharma Co Ltd, and is included in one hundred and twenty-six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Propranolol hydrochloride has sixty-one patent family members in thirty-two countries.

There are twenty-two drug master file entries for propranolol hydrochloride. Thirty-nine suppliers are listed for this compound.

Summary for propranolol hydrochloride
Recent Clinical Trials for propranolol hydrochloride

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

SponsorPhase
Shanghai Children's Medical CenterPhase 4
Foundation for Anesthesia Education and ResearchPhase 2
Duke UniversityPhase 2

See all propranolol hydrochloride clinical trials

Pharmacology for propranolol hydrochloride
Medical Subject Heading (MeSH) Categories for propranolol hydrochloride
Paragraph IV (Patent) Challenges for PROPRANOLOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
INDERAL LA CAPSULE, EXTENDED RELEASE;ORAL propranolol hydrochloride 018553

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
Purepac Pharm PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070757-001 Nov 3, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride SOLUTION;ORAL 070690-001 May 15, 1987 RX No Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983 AB RX Yes 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

Expired US Patents for propranolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Ayerst INDERAL propranolol hydrochloride SUSPENSION;ORAL 019536-001 Dec 12, 1986   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-004 Mar 18, 1987   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-003 Apr 19, 1983   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Harvard Business School
Express Scripts
Boehringer Ingelheim

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