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LOPRESSOR

NDA

METOPROLOL FUMARATE | N019786 | NOVARTIS PHARMACEUTICALS CORP

4 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services Inc. FDA-2002-P-0505 · 6 docket documents Lachman Consultant Services, Inc., filed this citizen petition on behalf of a client requesting that the FDA declare Metoprolol Tartrate Tablets USP, 25 mg suitable for consideration in an abbreviated new drug application (ANDA) under Section 505(j)(2)(C), with Lopressor (Metoprolol Tartrate) Tablet	Other	2018-12-04	Granted	Lachman Consultant Services Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

188 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 128 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
Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease NCT03566667	Phase 4	Active	Ole Frobert, MD, PhD	1,713	2018-06-12 → 2026-04-30
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)NCT03504956	N/A	Recruiting	Cedars-Sinai Medical Center	150	2018-07-30 → 2026-12-31
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure NCT00497003	Phase 4	Completed	Bispebjerg Hospital	50	2004-02 → 2007-10
Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery NCT02484859	Phase 4	Completed	Recep Tayyip Erdogan University	88	2015-07 → 2016-02
Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life NCT00999102	Phase 4	Completed	Weill Medical College of Cornell University	37	2009-10 → 2011-01
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)NCT01422616	Phase 3	Completed	The George Institute	4,587	2012-03 → 2018-08
Metoprolol to Reduce Perioperative Myocardial Injury NCT03138603	Phase 3	Completed	University of Chicago	72	2016-12 → 2023-08-29
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone NCT00391846	Phase 4	Completed	AstraZeneca	252	2006-10 → 2009-01
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients NCT01213173	Phase 4	Completed	AstraZeneca	251	2010-10 → 2011-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ESTEVE QUIMICA SAInactiveMETOPROLOL FUMARATE

DMF 105461993

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

Products (4)

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#001 — EQ 100MG TARTRATE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 27, 1989

No patent or exclusivity listings for this strength.

#002 — EQ 200MG TARTRATE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 27, 1989

#003 — EQ 300MG TARTRATE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 27, 1989

#004 — EQ 400MG TARTRATE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 27, 1989