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Last Updated: May 26, 2022

Propranolol hydrochloride - Generic Drug Details


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What are the generic drug sources for propranolol hydrochloride and what is the scope of freedom to operate?

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

Propranolol hydrochloride has forty-seven patent family members in thirty-one countries.

There are ten drug master file entries for propranolol hydrochloride. Forty suppliers are listed for this compound.

Summary for propranolol hydrochloride
International Patents:47
US Patents:2
Tradenames:6
Applicants:42
NDAs:125
Drug Master File Entries: 10
Finished Product Suppliers / Packagers: 40
Raw Ingredient (Bulk) Api Vendors: 138
Clinical Trials: 307
Patent Applications: 5,841
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in propranolol hydrochloride?propranolol hydrochloride excipients list
DailyMed Link:propranolol hydrochloride at DailyMed
Recent Clinical Trials for propranolol hydrochloride

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

SponsorPhase
Tianjin Medical University General HospitalPhase 2
Roswell Park Cancer InstituteN/A
Iqvia Pty LtdPhase 1

See all propranolol hydrochloride clinical trials

Pharmacology for propranolol hydrochloride
Medical Subject Heading (MeSH) Categories for propranolol hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for propranolol hydrochloride

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
Nortec Dev Assoc PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078065-001 Jan 26, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amta PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212026-004 Jan 6, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078022-004 Feb 15, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-001 Apr 19, 1983 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Inwood Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 072501-001 Apr 11, 1989 DISCN 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

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 See Plans and Pricing See Plans and Pricing
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-003 Apr 19, 1983 See Plans and Pricing See Plans and Pricing
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-004 Mar 18, 1987 See Plans and Pricing See Plans and Pricing
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-002 Mar 12, 2003 See Plans and Pricing See Plans and Pricing
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-001 Mar 12, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for propranolol hydrochloride

Country Patent Number Title Estimated Expiration
Hong Kong 1148940 USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS See Plans and Pricing
European Patent Office 2050441 Utilisation de bêtabloquants pour la fabrication d'un médicament pour le traitement d'hémangiomes (Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas) See Plans and Pricing
Hong Kong 1140530 USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS See Plans and Pricing
European Patent Office 2233135 Utilisation de bêtabloquants pour la fabrication d'un médicament pour le traitement d'hémangiomes (Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas) See Plans and Pricing
Tunisia 2010000170 USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Merck
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Moodys
McKinsey

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