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Last Updated: July 6, 2020

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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, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, West-ward Pharms Int, and Hq Spclt Pharma, and is included in ten NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esmolol hydrochloride has forty-five patent family members in twenty-five countries.

There are eight drug master file entries for esmolol hydrochloride. Eleven suppliers are listed for this compound.

Recent Clinical Trials for esmolol hydrochloride

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

SponsorPhase
Wake Forest University Health SciencesPhase 2/Phase 3
Kasr El Aini HospitalN/A
Zagazig UniversityPhase 2

See all esmolol hydrochloride clinical trials

Pharmacology for esmolol hydrochloride
Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BREVIBLOC IN PLASTIC CONTAINER INJECTABLE;INJECTION esmolol hydrochloride 019386 2014-01-31
BREVIBLOC INJECTABLE;INJECTION esmolol hydrochloride 019386 2014-01-31
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER INJECTABLE;INJECTION esmolol hydrochloride 019386 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
Mylan Institutional ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076474-001 May 2, 2005 AP RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 2003 DISCN No No   Start Trial   Start Trial Y   Start Trial
Baxter Hlthcare BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-005 Jan 27, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Labs Ltd ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 206608-001 Jun 8, 2018 AP RX No No   Start Trial   Start Trial   Start 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 esmolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 2003   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-003 Aug 15, 1988   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-004 Feb 16, 2001   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-005 Jan 27, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Baxter
Harvard Business School
Colorcon
Moodys

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