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ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

NDA

ESMOLOL HYDROCHLORIDE | N205703 | HQ SPECIALTY PHARMA CORP

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

Today

8829054

Mar. 15, 2033

8835505

Mar. 15, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

DELMAR CHEMICALS INCESMOLOL HYDROCHLORIDE

DMF 44751982

FINORGA SASESMOLOL HYDROCHLORIDE

DMF 68681987

TARO PHARMACEUTICAL INDUSTRIES LTDESMOLOL HYDROCHLORIDE

DMF 168632003

MSN LABORATORIES PRIVATE LTDESMOLOL HYDROCHLORIDE USP [ROUTE CODE-"EH"]

DMF 260242012

GLOBAL CALCIUM PRIVATE LTDESMOLOL HYDROCHLORIDE USP

DMF 368772023

GANES CHEMICALS INC PENNSVILLE DIVInactiveESMOLOL HYDROCHLORIDE

DMF 51261983

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 3, 2024	SUPPL -3	View Letter (PDF)
Apr 11, 2016	ORIG -1	View Letter (PDF)
Apr 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 2GM/100ML (20MG/ML)

RLD

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 7, 2016

#001 — 2.5GM/250ML (10MG/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 7, 2016

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8829054	Mar 15, 2033	—	—	Yes	—	—
8835505	Mar 15, 2033	—	—	Yes	—	—