Viewing data from:

PROLENSA

NDA

BROMFENAC SODIUM | N203168 | BAUSCH AND LOMB INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

9517220

Nov. 11, 2033

10085958

Nov. 19, 2032

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

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SENJU PHARMACEUTICAL CO., LTD et al v. AUROBINDO PHARMA USA INC. et al 3:2019cv13348 9 patentsANDA 212964bromfenac ophthalmic solution	D.N.J.	2019-06-03	Terminated 2020-01-07	—
SENJU PHARMACEUTICAL CO., LTD. et al v. AMNEAL PHARMACEUTICALS LLC et al 3:2018cv16991 1 patentANDA 210962bromfenac	D.N.J.	2018-12-07	Terminated 2019-01-03	—
SENJU PHARMACEUTICAL CO., LTD. et al v. HI-TECH PHARMACAL CO. INC. et al 1:2016cv02270 6 patentsANDA 208985Bromfenac	D.N.J.	2016-04-22	Terminated 2017-02-16	—
SENJU PHARMACEUTICAL CO., LTD. et al v. WATSON LABORATORIES, INC. et al 1:2016cv01522 1 patentANDA 206085Bromfenac	D.N.J.	2016-03-18	Terminated 2017-01-30	—
SENJU PHARMACEUTICAL CO., LTD. et al v. LUPIN, LTD. et al 1:2014cv00667 1 patentANDA 206027Bromfenac	D.N.J.	2014-01-31	Terminated 2016-08-29	—

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 Prolensa (2023)

Total Spending

$94.5M

Total Claims

252,440

Beneficiaries

144,112

Avg Cost/Unit

$118.17

Spending Trend

$67.3M(2019)→$61.1M(2020)→$76.9M(2021)→$88.1M(2022)→$94.5M(2023)

YoY Change:+7.0%

5yr CAGR:+7.0%

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

API Supply Chain11 active DMFs3 inactive

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

SENJU PHARMACEUTICAL CO LTDBROMFENAC SODIUM

DMF 164142003

ALP PHARM BEIJING CO LTDBROMFENAC SODIUM HYDRATE

DMF 230312009

YS LIFE SCIENCE CO LTDBROMFENAC SODIUM SESQUIHYDRATE

DMF 236532010

ARCHIMICA SPABROMFENAC SODIUM

DMF 237042010

CHEMWERTH INCBROMFENAC SODIUM (SESQUIHYDRATE)

DMF 245212011

INDOCO REMEDIES LTDBROMFENAC SODIUM

DMF 252452011

MATRIX PHARMACORP PRIVATE LTDBROMFENAC SODIUM

DMF 253152011

MICRO LABS LTDBROMFENAC SODIUM SESQUIHYDRATE

DMF 278002013

FARMAK ASBROMFENAC SODIUM

DMF 389222023

MEDILUX LABORATORIES PVT LTDBROMFENAC SODIUM HYDRATE

DMF 405112024

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDBROMFENAC SODIUM

DMF 408112024

LONZA RIVERSIDEInactiveBROMFENAC SODIUM SESQUIHYDRATE

DMF 105901993

STERLING WISCONSIN LLCInactiveBROMFENAC SODIUM (FP-098)

DMF 229152009

DR REDDYS LABORATORIES LTDInactiveBROMFENAC SODIUM SESQUIHYDRATE

DMF 251852011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 19, 2025	SUPPL -5	View Letter (PDF)
Apr 10, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.07% ACID

RLDAB

2 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 5, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9517220	Nov 11, 2033	—	—	—		—
10085958	Nov 19, 2032	—	—	Yes	—	—