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, 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, Endo Operations, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Purepac Pharm, Sandoz, Schering, Strides Pharma, Superpharm, Teva, 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. Forty 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:	40
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	331
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
Sir Run Run Shaw Hospital	N/A
Unity Health Toronto	N/A

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
Mylan	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070213-005	Apr 8, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pierre Fabre Derma	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071288-001	Oct 22, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071183-001	Oct 6, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nortec Dev Assoc	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078065-003	Jan 26, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Northstar Hlthcare	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	078213-004	Jan 10, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	⤷ Sign Up	⤷ Sign Up
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	⤷ Sign Up	⤷ Sign Up
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	⤷ Sign Up	⤷ Sign Up
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986	⤷ Sign Up	⤷ Sign Up
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983	⤷ Sign Up	⤷ Sign Up
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	⤷ Sign Up	⤷ Sign Up
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	⤷ Sign Up	⤷ Sign Up
>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	I531365		⤷ Sign Up
Austria	E512661		⤷ Sign Up
South Korea	101562627		⤷ Sign Up
Japan	5552700		⤷ Sign Up
Slovenia	2233135		⤷ Sign Up
China	103169971	Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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