ESMOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for esmolol hydrochloride and what is the scope of patent protection?

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:	109
Patent Applications:	1,049
Formulation / Manufacturing:	see details
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
Instituto de Salud Carlos III	Phase 3
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 3
Xiumei Song	Phase 4

See all ESMOLOL HYDROCHLORIDE clinical trials

Pharmacology for ESMOLOL HYDROCHLORIDE

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

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

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	205520-001	Jul 23, 2015	AP	RX	No	No
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016		RX	Yes	Yes			Y
Sagent Pharms Inc	ESMOLOL HYDROCHLORIDE	esmolol hydrochloride	INJECTABLE;INJECTION	207107-002	Jun 8, 2018	AP	RX	No	No
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703-002	Apr 7, 2016		RX	Yes	Yes			Y

Expired US Patents for ESMOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988

International Patents for ESMOLOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2014228155	Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
China	105263809	Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
European Patent Office	2948379	COMPOSITION PHARMACEUTIQUE DE COSOLVANTS PRÊTE À L'UTILISATION DANS DES RÉCIPIENTS DE MATIÈRE PLASTIQUE FLEXIBLES MODIFIÉS (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER)
South Korea	20150132835	변형된 가요성 플라스틱 용기에서 즉시 사용가능한 공용매 약학 조성물 (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER)