Viewing data from:

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Bepreve (2023)

Total Spending

$3.0M

Total Claims

7,621

Beneficiaries

3,305

Avg Cost/Unit

$55.02

Spending Trend

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

YoY Change:+6.0%

5yr CAGR:+6.4%

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