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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

3 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	—
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Bystolic (2023)

Total Spending

$23.9M

Total Claims

73,748

Beneficiaries

26,388

Avg Cost/Unit

$5.13

Spending Trend

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

YoY Change:+13.9%

5yr CAGR:+1.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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#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