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Last Updated: April 16, 2024

PROPRANOLOL HYDROCHLORIDE Drug Patent 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, Lupin Ltd, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Pai Holdings Pharm, Ani 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, Roxane, Sandoz, Schering, Strides Pharma, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Rising. and is included in one hundred and thirty-eight NDAs.

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

Summary for PROPRANOLOL HYDROCHLORIDE

US Patents:	0
Applicants:	41
NDAs:	138
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	329
Patent Applications:	3,873
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

Drug patent expirations by year for PROPRANOLOL HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for PROPRANOLOL HYDROCHLORIDE

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071976-001	Apr 6, 1988	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070213-004	Nov 19, 1985	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Farmaceutica	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	077760-001	Jan 31, 2008	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078311-004	Mar 6, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs Teva	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070550-001	Apr 11, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070381-001	Mar 19, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipca Labs Ltd	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	078955-005	Jun 2, 2008	AB	RX	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

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