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ZEBETA

NDA

BISOPROLOL FUMARATE | N019982 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC

2 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

6 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-4159 · 9 docket documents The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bisoprolol Fumarate Tablets, 1.25 mg, suitable for submission as an Abbreviated New Drug Appli	Suitability	2024-09-03	Denied	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Hyman, Phelps, & McNamara, P.C FDA-2023-P-4874 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Bisoprolol Tablets in 2.5 mg and 7.5 mg strengths suitable for submission of an Abbreviated New Drug Application, with ZEBETA (bisoprolol	Suitability	2023-11-03	Partially Denied	Hyman, Phelps, & McNamara, P.C
Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0125 · 6 docket documents The law firm Hyman, Phelps & McNamara filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Bisoprolol Tablets in 2.5 mg and 7.5 mg strengths suitable for submission as	Suitability	2021-01-28	Partially Denied	Hyman, Phelps & McNamara P.C.
Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0037 · 6 docket documents The law firm Hyman, Phelps & McNamara PC filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Bisoprolol Tablets in 2.5 mg (unscored) and 7.5 mg (scored) strengths suitable	Suitability	2021-01-11	Withdrawn	Hyman, Phelps & McNamara PC
Trigen Laboratories (BioKey, Inc.) - Citizen Petition FDA-2013-P-0299 · 4 docket documents Trigen Laboratories, through authorized agent BioKey Inc., submitted this citizen petition on March 4, 2013, requesting that the FDA amend the Orange Book to designate Sandoz and/or Mylan bisoprolol fumarate tablets as additional reference listed drugs for the 10 mg strength because TEVA Womens' ZEB	505(q)	2013-03-26	Denied	—
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0177 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Bisoprolol Fumarate and Hydrochlorothiazide Tablets in strengths of 5 mg/12.5 mg, 10 mg/12.5 mg, and 20 mg/12.5 mg suitable for submissi	Other	2008-05-06	Partially Denied	Lachman Consultant Services, Inc.

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

Clinical Trials

57 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 40 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
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants NCT03226275	Phase 1	Completed	Merck KGaA, Darmstadt, Germany	32	2017-08-09 → 2017-09-09
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.NCT01104558	Phase 4	Completed	Merck KGaA, Darmstadt, Germany	100	2008-12 → 2010-07
Curing Atrial Fibrillation in Heart Failure NCT00292162	N/A	Completed	NHS Greater Glasgow and Clyde	41	2007-01 → 2009-07
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers NCT03485482	Phase 3	Completed	Ain Shams University	18	2018-03-01 → 2018-03-23
Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity NCT00323973	Phase 3	Completed	Fundación Cardiovascular de Colombia	500	2003-07 → 2006-07
Effects of Beta-blockade on Cardiopulmonary Exercise Testing NCT02106286	Early Phase 1	Completed	Michelle Mossa	55	2011-02 → 2013-12
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)NCT02171988	Phase 4	Completed	Seoul National University Hospital	150	2014-03 → 2016-12
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes NCT01190436	Phase 4	Completed	Merck KGaA, Darmstadt, Germany	125	2009-12 → 2011-12

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

Medicare Part D Spending

CMS annual spending data for Bisoprolol Fumarate (2024)

Total Spending

$30.2M

Total Claims

1,091,996

Beneficiaries

285,708

Avg Cost/Unit

$0.36

Spending Trend

$30.9M(2019)→$37.0M(2020)→$40.4M(2021)→$41.5M(2022)→$43.8M(2023)→$30.2M(2024)

YoY Change:-36.7%

5yr CAGR:-12.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs2 inactive

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

MERCK KGAABISOPROLOL FUMARATE 2:1

DMF 80241989

CORDEN PHARMA CHENOVEBISOPROLOL FUMARATE

DMF 139101998

MOEHS IBERICA SLBISOPROLOL FUMARATE

DMF 150832000

UNICHEM LABORATORIES LTDBISOPROLOL FUMARATE USP

DMF 163982003

APITORIA PHARMA PRIVATE LTDBISOPROLOL FUMARATE USP

DMF 187812005

TAIWAN BIOTECH CO LTDBISOPROLOL FUMARATE

DMF 201202006

AREVIPHARMA GMBHBISOPROLOL FUMARATE

DMF 232412009

IPCA LABORATORIES LTDBISOPROLOL FUMARATE USP (PROCESS II)

DMF 266672013

PIRAMAL PHARMA LTDBISOPROLOL FUMARATE

DMF 291232015

SUPRIYA LIFESCIENCE LTDBISOPROLOL FUMARATE USP

DMF 356502021

MEDILUX LABORATORIES PVT LTDBISOPROLOL FUMARATE

DMF 358302021

MICRO LABS LTDBISOPROLOL FUMARATE USP

DMF 376012022

MSN PHARMACHEM PRIVATE LTDBISOPROLOL FUMARATE USP

DMF 414262025

CHONGQING LUMMY PHARMACEUTICAL CO LTDInactiveBISOPROLOL FUMARATE USP

DMF 198072006

IPCA LABORATORIES LTDInactiveBISOPROLOL FUMARATE USP

DMF 241202010

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2011	SUPPL -16	View Letter (PDF)
Sep 26, 2007	SUPPL -14	View Letter (PDF)
Jul 1, 2004	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 1992

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 1992