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Last Updated: April 25, 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
Chartwell Injectable	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	075792-001	Aug 29, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Inwood Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	072502-001	Apr 11, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amta	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212026-004	Jan 6, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070380-001	Mar 19, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Adare Pharms Inc	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078703-003	Jul 15, 2011	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

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
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	⤷ 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
Russian Federation	2010112816	ПРИМЕНЕНИЕ БЛОКА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ	⤷ Try a Trial
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)	⤷ Try a Trial
Cyprus	1112604		⤷ Try a Trial
Malaysia	156750	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS	⤷ Try a Trial
Brazil	PI0816536	uso de um beta bloqueador	⤷ Try a Trial
Japan	5552700		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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