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Last Updated: December 5, 2023

Propranolol hydrochloride - Generic Drug Details

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What are the generic drug sources for propranolol hydrochloride and what is the scope of freedom to operate?

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, Amici, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, 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. Forty suppliers are listed for this compound.

Summary for propranolol hydrochloride

International Patents:	47
US Patents:	2
Tradenames:	6
Applicants:	42
NDAs:	125
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	40
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

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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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
Wyeth Pharms	INDERAL	propranolol hydrochloride	TABLET;ORAL	016418-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms Usa Inc	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090321-001	Mar 25, 2011	AB	RX	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
Fosun Pharma	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	076400-001	Feb 26, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duramed Pharms Barr	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071327-001	Oct 1, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071517-001	Jun 8, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Purepac Pharm	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070817-001	Nov 3, 1986		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
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	021438-001	Mar 12, 2003	⤷ Try a Trial	⤷ Try a Trial
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	018553-001	Apr 19, 1983	⤷ 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	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	018553-002	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
South Korea	20150110827	혈관종 치료용 의약품 제조용 베타 차단제의 용도 (USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS)	⤷ Try a Trial
Poland	2233135		⤷ Try a Trial
Saudi Arabia	08290744	إستعمال محصر للبيتا لصناعة دواء لمعالجة ورم وعائى (Use of a Beta Blocker for the Manufacture of a Medicament for the Treatment of Hemangiomas)	⤷ Try a Trial
China	103169971	Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas	⤷ Try a Trial
Panama	8799401	USO DE UN BETA BLOQUEANTE PARA LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE LOS HEMANGIOMAS	⤷ Try a Trial
Japan	5552700		⤷ Try a Trial
Croatia	P20120765		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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