Viewing data from:

BETOPTIC S

NDA

BETAXOLOL HYDROCHLORIDE | N019845 | NOVARTIS PHARMACEUTICALS CORP

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension NCT02617459	Phase 3	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	366	2019-01-04 → 2021-07-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$42.88

per ml

Lowest NADAC/Unit

$42.62

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078072915BETOPTIC S 0.25% EYE DROP	$42.88	ML	Brand	—	2026-01-07
00078072910BETOPTIC S 0.25% EYE DROP	$42.62	ML	Brand	—	2026-01-07

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$269.46

Highest Price

$526.54

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0729-10BETOPTIC 0.25% SUSP,OPH	$351.07	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0729-10BETOPTIC 0.25% SUSP,OPH	$269.46	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0729-15BETOPTIC 0.25% SUSP	$526.54	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0729-15BETOPTIC 0.25% SUSP	$401.93	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Betoptic S (2024)

Total Spending

$3.7M

Total Claims

7,033

Beneficiaries

1,971

Avg Cost/Unit

$35.61

Spending Trend

$6.9M(2019)→$6.2M(2020)→$5.5M(2021)→$4.8M(2022)→$4.4M(2023)→$3.7M(2024)

YoY Change:-1.1%

5yr CAGR:+3.7%

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

API Supply Chain3 active DMFs5 inactive

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

LUSOCHIMICA SPABETAXOLOL HYDROCHLORIDE

DMF 107271994

OLON SPABETAXOLOL HYDROCHLORIDE

DMF 172352004

INDOCO REMEDIES LTDBETAXOLOL HYDROCHLORIDE USP

DMF 253012011

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL

DMF 38001980

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL HYDROCHLORIDE

DMF 54641984

FINORGA SASInactiveBETAXOLOL HYDROCHLORIDE

DMF 62861986

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveBETAXOLOL HYDROCHLORIDE, USP

DMF 126381997

SIFAVITOR SRLInactiveBETAXOLOL HYDROCHLORIDE

DMF 126801997

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 10, 2021	SUPPL -30	View Letter (PDF)
Jan 31, 2017	SUPPL -25	View Letter (PDF)
May 14, 2008	SUPPL -21	View Letter (PDF)
Jun 14, 2007	SUPPL -20	View Letter (PDF)
Jun 8, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.25% BASE

RLD

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Dec 29, 1989

No patent or exclusivity listings for this strength.