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BEPREVE

NDA

BEPOTASTINE BESILATE | N022288 | BAUSCH AND LOMB INC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis NCT00586664	Phase 3	Completed	Bausch & Lomb Incorporated	130	2007-10 → 2008-06
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis NCT01900054	Phase 3	Completed	Tanabe Pharma Corporation	58	2013-06 → 2013-11
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg NCT01897428	Phase 1	Completed	Korea University Anam Hospital	26	2011-04 → 2011-08
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber NCT01222299	Phase 1/2	Completed	Bausch & Lomb Incorporated	89	2010-05 → 2010-08
Comparing Patient Satisfaction With Pataday or Bepreve NCT01450176	N/A	Completed	McCabe Vision Center	30	2011-09 → 2011-12
Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)NCT01753739	Phase 2	Completed	Bausch & Lomb Incorporated	617	2013-01 → 2013-05
Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"NCT03932435	N/A	Completed	Dong-A ST Co., Ltd.	32	2019-04-23 → 2019-05-28
Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis NCT00424398	Phase 2/3	Completed	Bausch & Lomb Incorporated	107	2007-02
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis NCT01578278	Phase 2	Completed	Bausch & Lomb Incorporated	606	2011-12 → 2012-08
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis NCT01861522	Phase 3	Completed	Tanabe Pharma Corporation	473	2013-04 → 2013-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs (1 brand, 4 generic)

Highest NADAC/Unit

$55.94

per ml

Lowest NADAC/Unit

$8.56

per ml

Brand NDCs

Generic NDCs

Avg Brand: $55.94

Avg Generic: $10.06

82% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208062902BEPREVE 1.5% EYE DROPS	$55.94	ML	Brand	$11.56	2026-03-18
82260063005BEPOTASTINE 1.5% EYE DROP	$11.56	ML	Generic	—	2026-06-17
24208063005BEPOTASTINE 1.5% EYE DROP	$11.56	ML	Generic	—	2026-06-17
82260063010BEPOTASTINE 1.5% EYE DROP	$8.56	ML	Generic	—	2026-06-17
24208063010BEPOTASTINE 1.5% EYE DROP	$8.56	ML	Generic	—	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

$11.47

Highest Price

$376.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24208-0629-01BEPREVE 1.5% OPHTHALMIC SOLN	$376.83	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0629-01BEPREVE 1.5% OPHTHALMIC SOLN	$376.83	Big4	Bausch & Lomb Americas Inc.	09/14/2027
82260-0630-05BEPOTASTINE BESILATE 1.5% SOLN,OPH	$55.28	FSS	Bausch & Lomb Americas Inc.	09/14/2027
82260-0630-05BEPOTASTINE BESILATE 1.5% SOLN,OPH	$11.47	Big4	Bausch & Lomb Americas Inc.	09/14/2027
82260-0630-10BEPOTASTINE BESILATE 1.5% SOLN,OPH	$118.58	FSS	Bausch & Lomb Americas Inc.	09/14/2027
82260-0630-10BEPOTASTINE BESILATE 1.5% SOLN,OPH	$29.35	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0629-02BEPREVE 1.5% OPHTHALMIC SOLN	$197.02	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0629-02BEPREVE 1.5% OPHTHALMIC SOLN	$197.02	Big4	Bausch & Lomb Americas Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Bepreve (2024)

Total Spending

$1.5M

Total Claims

3,553

Beneficiaries

1,193

Avg Cost/Unit

$54.52

Spending Trend

$18.8M(2019)→$18.3M(2020)→$18.3M(2021)→$11.2M(2022)→$3.0M(2023)→$1.5M(2024)

YoY Change:-0.9%

5yr CAGR:+4.3%

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

API Supply Chain5 active DMFs2 inactive

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

UBE CORPBEPOTASTINE BESILATE

DMF 199662006

BAL PHARMA LTDBEPOTASTINE BESILATE

DMF 273502013

BAL PHARMA LTDBEPOTASTINE BESILATE

DMF 273862013

ICROM SRLBEPOTASTINE BESILATE

DMF 274652013

MSN LABORATORIES PRIVATE LTDBEPOTASTINE BESILATE [ROUTE CODE - "BB"]

DMF 280122014

MEDICHEM MANUFACTURING (MALTA) LTDInactiveBEPOTASTINE BESILATE

DMF 271702013

MEDICHEM MANUFACTURING (MALTA) LTDInactiveBEPOTASTINE BESILATE

DMF 289012014

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 9, 2018	SUPPL -8	View Letter (PDF)
Jun 29, 2012	SUPPL -3	View Letter (PDF)
Sep 16, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.5%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 8, 2009

No patent or exclusivity listings for this strength.