Viewing data from:

LOPRESSOR

NDA

METOPROLOL TARTRATE | N219373 | RUBICON RESEARCH LTD

1 strength0 unique patents0 unique exclusivities

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

193 trials from ClinicalTrials.gov — 6 recruiting, 1 active, 129 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction NCT03778554	Phase 4	Active	Bispebjerg Hospital	2,760	2018-12-17 → 2035-12-10
Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)NCT07298993	Phase 4	By Invitation	Weill Medical College of Cornell University	240	2026-02-02 → 2029-04
Predicting Response and Exposure Changes in Cirrhosis for Effectiveness NCT07750587	N/A	Not Yet Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	45	2026-11-01 → 2028-12-01
Comparing Two Heart Medicines for Fast, Irregular Heartbeat (Atrial Fibrillation)NCT07706075	Phase 4	Not Yet Recruiting	Muhammad Ali Javed	120	2027-01-01 → 2027-08-01
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy NCT07755904	Phase 3	Not Yet Recruiting	Braveheart Bio, Inc.	210	2026-10 → 2028-11
Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score NCT07490067	Phase 4	Recruiting	University of Michigan	100	2026-07 → 2029-07
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)NCT03504956	N/A	Recruiting	Cedars-Sinai Medical Center	150	2018-07-30 → 2027-12-31
Curing Atrial Fibrillation in Heart Failure NCT00292162	N/A	Completed	NHS Greater Glasgow and Clyde	41	2007-01 → 2009-07
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus NCT02737891	Phase 2	Completed	Saniona	60	2016-04 → 2017-03
Beta-2 Polymorphisms and Beta Receptor Selectivity NCT00214318	N/A	Completed	University of Wisconsin, Madison	25	2005-01 → 2007-02

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 1 NDC

Highest NADAC/Unit

$1.20

per ml

Lowest NADAC/Unit

$1.20

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
30698046430LOPRESSOR 10 MG/ML ORAL SOLN	$1.20	ML	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain15 active DMFs15 inactive

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

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLMETOPROLOL TARTRATE

DMF 56051984

TAPI NL BVMETOPROLOL TARTRATE USP

DMF 68381987

TAPI NL BVMETOPROLOL TARTRATE

DMF 71511987

MOEHS IBERICA SLMETOPROLOL TARTRATE

DMF 73061988

IPCA LABORATORIES LTDMETOPROLOL TARTRATE USP

DMF 158502002

SUN PHARMACEUTICAL INDUSTRIES LTDMETOPROLOL TARTRATE USP

DMF 159952002

APITORIA PHARMA PRIVATE LTDMETOPROLOL TARTRATE USP

DMF 192832006

IPCA LABORATORIES LTDMETOPROLOL TARTRATE USP (PROCESS III)

DMF 212542008

CTX LIFE SCIENCES PVT LTDMETOPROLOL TARTRATE USP

DMF 213472008

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDMETOPROLOL TARTRATE

DMF 240382010

ALEMBIC PHARMACEUTICALS LTDMETOPROLOL TARTRATE USP

DMF 245262011

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDMETOPROLOL TARTRATE USP

DMF 288212014

MSN LIFE SCIENCES PRIVATE LTDMETOPROLOL TARTRATE USP

DMF 347052020

KOPRAN RESEARCH LABORATORIES LTDMETOPROLOL TARTRATE USP

DMF 349032020

ATUL BIOSCIENCE LTDMETOPROLOL TARTRATE USP

DMF 423122025

CAMBREX PROFARMACO MILANO SRLInactiveMETOPROLOL TARTRATE

DMF 48191982

ERREGIERRE SPAInactiveMETOPROLOL TARTRATE USP

DMF 62781986

CIPLA LTDInactiveMETOPROLOL TARTRATE

DMF 65991986

NEWPORT PHARMACEUTICALS IRELANDInactiveMETOPROLOL TARTRATE

DMF 81421989

RECORDATI INDUSTRIA CHIMICA SPAInactiveMETOPROLOL TARTRATE

DMF 88381990

SIEGFRIED AGInactiveMETOPROLOL TARTRATE

DMF 91101991

PLIVA CROATIA LTDInactiveMETOPROLOL TARTRATE

DMF 95391992

SYNCHEM CHEMICALS PVT LTDInactiveMETOPROLOL TARTRATE

DMF 98381992

FREEDOM CHEMICAL DIAMALT GMBHInactiveMETOPROLOL TARTRATE

DMF 98911992

SLOVAKOFARMA LTDInactiveMETOPROLOL TARTRATE

DMF 116301995

COSMA SPAInactiveMETOPROLOL TARTRATE

DMF 143241999

MOEHS IBERICA SLInactiveMETOPROLOL TARTRATE USP

DMF 149072000

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMETOPROLOL TARTRATE USP

DMF 218652008

POLYDRUG LABORATORIES PVT LTDInactiveMETOPROLOL TARTRATE USP

DMF 219412008

CTX LIFE SCIENCES PVT LTDInactiveMETOPROLOL TARTRATE USP (ROUTE-I)

DMF 229362009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Apr 10, 2025

No patent or exclusivity listings for this strength.