FDA Orange Book · active-ingredient family
Esmolol hydrochloride
Esmolol hydrochloride: 2 brands, 11 generics; first approved Aug 15, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
2
Next patent expiry
Mar 15, 2033
in 6 yr 8 mo
Brand (NDA) products
Originator applications
- HQ SPCLT PHARMANDA 20570320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/250ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 2GM/100ML (20MG/ML) SOLUTION INTRAVENOUS Rx — - BAXTER HLTHCARENDA 01938620035 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP 10MG/ML INJECTABLE INJECTION Rx AP 20MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- ESMOLOL HYDROCHLORIDEAMNEALANDA 21660320222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEHQ SPCLT PHARMAANDA 21417220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEEUGIA PHARMAANDA 21624420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEGLANDANDA 2085382019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEMYLAN LABS LTDANDA 20660820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDESAGENT PHARMS INCANDA 20710720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEEUGIA PHARMAANDA 2055202015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEAM REGENTANDA 2011262015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ESMOLOL HYDROCHLORIDEFRESENIUS KABI USAANDA 07657320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 20MG/ML INJECTABLE INJECTION Discontinued — - ESMOLOL HYDROCHLORIDEMYLAN INSTITUTIONALANDA 0764742005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ESMOLOL HYDROCHLORIDEHIKMAANDA 0763232004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8835505 | in 6 yr 8 mo | Product | |
| 8829054 | in 6 yr 8 mo | Product |
Approval history
FDA approval span
First approval
38 yr 7 mo ago
Most recent approval
3 yr 1 mo ago
Approvals span 1988–2023 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Esmolol hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
