HEMANGEOL Drug Patent Profile

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When do Hemangeol patents expire, and what generic alternatives are available?

Hemangeol is a drug marketed by Pierre Fabre Derma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in thirty-one countries.

The generic ingredient in HEMANGEOL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hemangeol

A generic version of HEMANGEOL was approved as propranolol hydrochloride by INNOGENIX on October 22^nd, 1985.

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Summary for HEMANGEOL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	4
Patent Applications:	3,873
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HEMANGEOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEMANGEOL
What excipients (inactive ingredients) are in HEMANGEOL?	HEMANGEOL excipients list
DailyMed Link:	HEMANGEOL at DailyMed

Drug patent expirations by year for HEMANGEOL

Recent Clinical Trials for HEMANGEOL

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

Sponsor	Phase
Christiana Care Health Services	Phase 1
Columbia University	Phase 2
University of Missouri-Columbia	Early Phase 1

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Pharmacology for HEMANGEOL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for HEMANGEOL

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

Paragraph IV (Patent) Challenges for HEMANGEOL

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 HEMANGEOL

HEMANGEOL is protected by two US patents.

Patents protecting HEMANGEOL

Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD TO TREAT HEMANGIOMA.

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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
Pierre Fabre Derma	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pierre Fabre Derma	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	⤷ 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

International Patents for HEMANGEOL

See the table below for patents covering HEMANGEOL around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20100087012	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS	⤷ Try a Trial
Australia	2008313405	Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas	⤷ Try a Trial
New Zealand	584307	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration