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Last Updated: March 19, 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
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 3
Instituto de Salud Carlos IIIPhase 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
Eugia Pharma ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 216244-002 Mar 21, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 216244-001 Mar 21, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 207107-001 Jun 8, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 216603-002 Dec 13, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 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
Hq Spclt Pharma ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER esmolol hydrochloride SOLUTION;INTRAVENOUS 205703-001 Apr 7, 2016 ⤷  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 ⤷  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
World Intellectual Property Organization (WIPO) 2014143845 ⤷  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
Australia 2014228155 Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container ⤷  Try a Trial
South Korea 20150132835 변형된 가요성 플라스틱 용기에서 즉시 사용가능한 공용매 약학 조성물 (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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