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Last Updated: March 28, 2024

Esmolol hydrochloride - Generic Drug Details


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What are the generic drug 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.

Recent Clinical Trials for esmolol hydrochloride

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

SponsorPhase
Instituto de Salud Carlos IIIPhase 3
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 3
Xiumei SongPhase 4

See all esmolol hydrochloride clinical trials

Pharmacology 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
Hq Spclt Pharma ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER esmolol hydrochloride SOLUTION;INTRAVENOUS 205703-001 Apr 7, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Labs Ltd ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 206608-002 Jun 8, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hq Spclt Pharma ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride SOLUTION;INTRAVENOUS 205703-002 Apr 7, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

Expired US Patents for esmolol hydrochloride

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 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-005 Jan 27, 2003 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-003 Aug 15, 1988 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for esmolol hydrochloride

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 ⤷  Try a Trial
China 105263809 Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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