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BROMFENAC SODIUM

ANDA

BROMFENAC SODIUM | A210962 | AMNEAL EU LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BROMSITE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 31, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.07% ACID

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jul 29, 2024

No patent or exclusivity listings for this strength.