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Last Updated: April 24, 2024

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, Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, 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-six 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-nine suppliers are listed for this compound.

Summary for propranolol hydrochloride

International Patents:	47
US Patents:	2
Tradenames:	6
Applicants:	43
NDAs:	126
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	329
Patent Applications:	6,236
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for propranolol hydrochloride
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

Sponsor	Phase
AIDS Malignancy Consortium	Phase 2
Unity Health Toronto	N/A
University of New Mexico	Phase 4

See all propranolol hydrochloride clinical trials

Pharmacology for propranolol hydrochloride

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for propranolol hydrochloride

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solopak	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	070136-001	Apr 15, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roxane	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070520-001	Jul 7, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ivax Sub Teva Pharms	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	072068-001	Jul 29, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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

International Patents for propranolol hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Taiwan	200932207	Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas	⤷ Try a Trial
Japan	2011500661		⤷ Try a Trial
Hong Kong	1140530	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.