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BESIVANCE

NDA

BESIFLOXACIN HYDROCHLORIDE | N022308 | BAUSCH AND LOMB INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

Today

Nov. 7, 2030

Jan. 9, 2031

Mar. 12, 2030

Nov. 13, 2029

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Besivance (2023)

Total Spending

$10.6M

Total Claims

46,228

Beneficiaries

30,725

Avg Cost/Unit

$45.24

Spending Trend

$33.1M(2019)→$18.0M(2020)→$18.0M(2021)→$14.3M(2022)→$10.6M(2023)

YoY Change:+7.1%

5yr CAGR:+6.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs1 inactive

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

INDOCO REMEDIES LTDBESIFLOXACIN HYDROCHLORIDE

DMF 293032015

MICRO LABS LTDBESIFLOXACIN HYDROCHLORIDE

DMF 319892017

ALP PHARM BEIJING CO LTDBESIFLOXACIN HYDROCHLORIDE

DMF 326112018

MAITHRI DRUGS PRIVATE LTDBESIFLOXACIN HYDROCHLORIDE

DMF 358092021

RUYUAN HEC PHARM CO LTDInactiveBESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 321602017

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 5, 2018	SUPPL -13	View Letter (PDF)
Sep 24, 2012	SUPPL -3	View Letter (PDF)
Jun 2, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.6% BASE

RLD

4 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: May 28, 2009

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8415342	Nov 7, 2030	—	—	—		—
8481526	Jan 9, 2031	—	Yes	—	—	—
8604020	Mar 12, 2030	—	—	Yes	—	—
8937062	Nov 13, 2029	—	—	—		—