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Last Updated: December 3, 2022

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, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, and Hq Spclt Pharma, and is included in eleven 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. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for esmolol hydrochloride

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

SponsorPhase
Kafrelsheikh UniversityN/A
Aretaieion University HospitalN/A
Chinese Medical AssociationN/A

See all esmolol hydrochloride clinical trials

Pharmacology for esmolol hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for esmolol hydrochloride
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
Baxter Hlthcare BREVIBLOC IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-004 Feb 16, 2001 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sagent Pharms Inc ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 207107-002 Jun 8, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 206608-002 Jun 8, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Institutional ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076474-001 May 2, 2005 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-005 Jan 27, 2003 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 2003 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 2003 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare BREVIBLOC IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-004 Feb 16, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014143845 See Plans and Pricing
China 105263809 Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container See Plans and Pricing
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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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