Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Mallinckrodt
Moodys
AstraZeneca
McKesson

Last Updated: January 30, 2023

Propranolol hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, 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, Pai Holdings Pharm, 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. Thirty-six suppliers are listed for this compound.

Recent Clinical Trials for propranolol hydrochloride

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

SponsorPhase
West China Tianfu HospitalN/A
Chengdu Shangjin Nanfu HospitalN/A
United States Department of DefensePhase 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 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
Watson Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070140-001 Jul 30, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070382-001 Mar 19, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070213-004 Nov 19, 1985 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
Duramed Pharms Barr PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071327-001 Oct 1, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vintage Pharms PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070221-005 Sep 24, 1986 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs Inc PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071976-002 May 13, 1986 AB 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

Expired US Patents for propranolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-001 Mar 12, 2003 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 INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983 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 018553-001 Apr 19, 1983 See Plans and Pricing See Plans and Pricing
Wyeth Ayerst INDERAL propranolol hydrochloride SUSPENSION;ORAL 019536-001 Dec 12, 1986 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
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
Cyprus 1112604 See Plans and Pricing
Japan 2011500661 See Plans and Pricing
South Korea 101562627 See Plans and Pricing
Russian Federation 2010112816 ПРИМЕНЕНИЕ БЛОКА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ See Plans and Pricing
Portugal 2233135 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Harvard Business School
Express Scripts
Boehringer Ingelheim

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.