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BROMFENAC SODIUM

ANDA

BROMFENAC SODIUM | A201211 | COASTAL PHARMACEUTICALS

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 4 - Draft Guidance on Bromfenac Sodium RE Suitability Petition fro... FDA-2023-P-4359 Pharmobedient Consulting, LLC filed a petition regarding bromfenac sodium requesting FDA guidance on the suitability of the drug substance for use in abbreviated new drug applications (ANDAs), specifically addressing regulatory reference eligibility and quality standards.	Suitability	2023-10-05	Open	Pharmobedient Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Bromfenac Sodium (2023)

Total Spending

$8.1M

Total Claims

49,848

Beneficiaries

23,960

Avg Cost/Unit

$72.11

Spending Trend

$4.5M(2019)→$4.4M(2020)→$5.8M(2021)→$6.5M(2022)→$8.1M(2023)

YoY Change:-7.0%

5yr CAGR:-3.9%

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

1 letter from Drugs@FDA

Date	Submission	Document
May 16, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09% ACID

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 11, 2011

No patent or exclusivity listings for this strength.