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BYSTOLIC

NDA

NEBIVOLOL HYDROCHLORIDE | N021742 | ALLERGAN SALES LLC

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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan Sales, LLC et al v. Ajanta Pharma Ltd. et al 1:2019cv01249 1 patentANDA 213349nebivolol hydrochloride	D. Del.	2019-07-02	Terminated 2020-01-02	—
Allergan Sales LLC et al v. Aurobindo Pharma USA Inc. et al 1:2018cv00118	D. Del.	2018-01-19	Terminated 2018-09-13	—
Forest Laboratories, Inc. et al v. Indchemie Health Specialties PVT. LTD. et al 1:2012cv01855 1 patentANDA 203828, 203741nebivolol hydrochloride	N.D. Ill.	2012-03-14	Terminated 2013-12-19	—
Forest Laboratories Inc. et al v. Torrent Pharmaceuticals Ltd. et al 1:2012cv00305 1 patentANDA 203966, 203683, 203659, 203821, 203825nebivolol hydrochloride	D. Del.	2012-03-13	Terminated 2012-06-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

79 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 61 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
Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy NCT01648634	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	51	2012-02-13 → 2021-07-20
The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease NCT00673075	Phase 4	Completed	Forest Laboratories	39	2008-05
Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension NCT00999752	N/A	Completed	InVasc Therapeutics, Inc.	40	2009-10 → 2010-05
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
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension NCT01202175	Phase 4	Completed	University of California, San Diego	50	2010-07 → 2013-06
Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients NCT01501929	Phase 4	Completed	University of Texas Southwestern Medical Center	32	2010-08 → 2015-12
Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)NCT01595516	Phase 4	Completed	University of Colorado, Boulder	44	2012-02 → 2017-10
A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients NCT00648895	Phase 3	Completed	Forest Laboratories	12	2007-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$6.46

per ea

Lowest NADAC/Unit

$6.42

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00456140230BYSTOLIC 2.5 MG TABLET	$6.46	EA	Brand	$0.1217	2026-06-17
00456140590BYSTOLIC 5 MG TABLET	$6.45	EA	Brand	$0.1042	2026-06-17
00456142090BYSTOLIC 20 MG TABLET	$6.43	EA	Brand	$0.1839	2026-06-17
00456141090BYSTOLIC 10 MG TABLET	$6.42	EA	Brand	$0.1474	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$138.63

Highest Price

$567.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-1410-90BYSTOLIC 10MG TAB	$567.18	FSS	Abbvie US LLC	07/31/2030
00456-1410-90BYSTOLIC 10MG TAB	$415.26	Big4	Abbvie US LLC	07/31/2030
00456-1402-30BYSTOLIC 2.5MG TAB	$189.07	FSS	Abbvie US LLC	07/31/2030
00456-1402-30BYSTOLIC 2.5MG TAB	$138.63	Big4	Abbvie US LLC	07/31/2030
00456-1405-90BYSTOLIC 5MGTAB	$567.18	FSS	Abbvie US LLC	07/31/2030
00456-1405-90BYSTOLIC 5MGTAB	$415.83	Big4	Abbvie US LLC	07/31/2030
00456-1420-90BYSTOLIC 20MG TAB	$567.18	FSS	Abbvie US LLC	07/31/2030
00456-1420-90BYSTOLIC 20MG TAB	$415.93	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Bystolic (2024)

Total Spending

$16.5M

Total Claims

41,207

Beneficiaries

9,360

Avg Cost/Unit

$5.74

Spending Trend

$454.4M(2019)→$480.4M(2020)→$415.4M(2021)→$74.4M(2022)→$23.9M(2023)→$16.5M(2024)

YoY Change:+11.8%

5yr CAGR:+3.4%

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

API Supply Chain13 active DMFs1 inactive

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

CADILA PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 211522007

FIS FABBRICA ITALIANA SINTETICI SPANEBIVOLOL HYDROCHLORIDE

DMF 227352009

TORRENT PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 229062009

MSN PHARMACHEM PRIVATE LTDNEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']

DMF 249162011

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE

DMF 252962011

HONOUR LAB LTDNEBIVOLOL HYDROCHLORIDE

DMF 286272014

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 297302015

MACLEODS PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 299962016

CORDEN PHARMA CHENOVENEBIVOLOL HYDROCHLORIDE

DMF 300522015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 308482016

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE (PROCESS-II)

DMF 310812016

SMAART PHARMACEUTTICALSNEBIVOLOL HYDROCHLORIDE

DMF 353322021

ALKEM LABORATORIES LTDNEBIVOLOL HYDROCHLORIDE

DMF 393132024

DR REDDYS LABORATORIES LTDInactiveNEBIVOLOL HYDROCHLORIDE

DMF 248212011

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 20, 2023	SUPPL -28	View Letter (PDF)
Dec 1, 2017	SUPPL -22	View Letter (PDF)
Dec 15, 2011	SUPPL -13	View Letter (PDF)
Feb 26, 2010	SUPPL -7	View Letter (PDF)
Jan 9, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — EQ 2.5MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 17, 2007

No patent or exclusivity listings for this strength.

#003 — EQ 5MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 17, 2007

#004 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 17, 2007

#005 — EQ 20MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 8, 2008