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Last Updated: April 10, 2021

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PROPRANOLOL HYDROCHLORIDE Drug Profile

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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, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Athenex Inc, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Morton Grove, Ani Pharms Inc, 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, Roxane, Sandoz, Schering, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Yaopharma Co Ltd. and is included in one hundred and thirty-nine NDAs.

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

Summary for PROPRANOLOL HYDROCHLORIDE

US Patents:	0
Applicants:	39
NDAs:	139
Suppliers / Packagers:	33
Bulk Api Vendors:	127
Clinical Trials:	279
Patent Applications:	3,369
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in PROPRANOLOL HYDROCHLORIDE?	PROPRANOLOL HYDROCHLORIDE excipients list
DailyMed Link:	PROPRANOLOL HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PROPRANOLOL HYDROCHLORIDE

Recent Clinical Trials for PROPRANOLOL HYDROCHLORIDE

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

Sponsor	Phase
Christiana Care Health Services	Phase 1
University of Pittsburgh	Phase 1/Phase 2
Bernhard Kuhn	Phase 1/Phase 2

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	NDA	Submissiondate
INDERAL LA	CAPSULE, EXTENDED RELEASE;ORAL	propranolol hydrochloride	018553

US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE

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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
Interpharm	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071371-001	May 5, 1987		DISCN	No	No	Start Trial	Start Trial				Start Trial
Purepac Pharm	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070816-001	Nov 3, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Hikma	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	SOLUTION;ORAL	070979-001	May 15, 1987		RX	No	Yes	Start Trial	Start Trial				Start Trial
Zydus Pharms Usa Inc	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090321-004	Mar 25, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Actavis Elizabeth	PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; propranolol hydrochloride	TABLET;ORAL	070851-001	May 15, 1986		DISCN	No	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

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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.

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