Esmolol hydrochloride - Generic Drug Details

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

Esmolol hydrochloride is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esmolol hydrochloride has seven patent family members in seven countries.

There are five drug master file entries for esmolol hydrochloride. Twelve suppliers are listed for this compound.

Summary for esmolol hydrochloride

International Patents:	7
US Patents:	2
Tradenames:	6
Applicants:	11
NDAs:	13
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	112
Patent Applications:	1,049
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esmolol hydrochloride
What excipients (inactive ingredients) are in esmolol hydrochloride?	esmolol hydrochloride excipients list
DailyMed Link:	esmolol hydrochloride at DailyMed

Recent Clinical Trials for esmolol hydrochloride

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

Sponsor	Phase
Muhammad Haroon Anwar	Phase 4
Pakistan Institute of Medical Sciences	Phase 4
Instituto de Salud Carlos III	Phase 3

See all esmolol hydrochloride clinical trials

Pharmacology for esmolol hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for esmolol hydrochloride

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREVIBLOC IN PLASTIC CONTAINER	Injection	esmolol hydrochloride	10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags	019386	1	2014-01-31

US Patents and Regulatory Information for esmolol 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
Eugia Pharma	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	216244-002	Mar 21, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	216244-001	Mar 21, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	201126-001	Feb 20, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	216603-002	Dec 13, 2022	AP	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 esmolol hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for esmolol hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Japan	2016515513	改良軟質プラスチック容器中のすぐに使用可能な共溶媒医薬組成物	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014143845		⤷ Sign Up
Canada	2906031	COMPOSITION PHARMACEUTIQUE DE COSOLVANTS PRETE A L'UTILISATION DANS DES RECIPIENTS DE MATIERE PLASTIQUE FLEXIBLES MODIFIES (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER)	⤷ Sign Up
China	105263809	Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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