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FDA Orange Book · active-ingredient family

Esmolol hydrochloride

Esmolol hydrochloride is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER · NDA 205703

2

Brand (NDA)

11

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERRLD×2HQ SPCLT PHARMANDA 205703—Apr 07, 2016
BREVIBLOCRLD×5BAXTER HLTHCARENDA 019386APFeb 25, 2003

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
ESMOLOL HYDROCHLORIDE×2AMNEALANDA 216603APDec 13, 2022
ESMOLOL HYDROCHLORIDE×2HQ SPCLT PHARMAANDA 214172APDec 02, 2022
ESMOLOL HYDROCHLORIDE×2EUGIA PHARMAANDA 216244APMar 21, 2022
ESMOLOL HYDROCHLORIDEGLANDANDA 208538APAug 14, 2019
ESMOLOL HYDROCHLORIDE×2MYLAN LABS LTDANDA 206608APJun 08, 2018
ESMOLOL HYDROCHLORIDE×2SAGENT PHARMS INCANDA 207107APJun 08, 2018
ESMOLOL HYDROCHLORIDEEUGIA PHARMAANDA 205520APJul 23, 2015
ESMOLOL HYDROCHLORIDEAM REGENTANDA 201126—Feb 20, 2015
ESMOLOL HYDROCHLORIDE×2FRESENIUS KABI USAANDA 076573—May 02, 2005
ESMOLOL HYDROCHLORIDEMYLAN INSTITUTIONALANDA 076474APMay 02, 2005
ESMOLOL HYDROCHLORIDEHIKMAANDA 076323APAug 10, 2004

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8835505Mar 15, 2033in 6 yr 10 mo
Product
8829054Mar 15, 2033in 6 yr 10 mo
Product

Esmolol hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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