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FIDAXOMICIN

ANDA

FIDAXOMICIN | A208443 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DIFICID(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. 2:2020cv00534 5 patentsANDA 208443fidaxomicin	D.N.J.	2020-01-16	Terminated 2020-02-13	—
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. et al 2:2015cv06541 5 patentsANDA 208443fidaxomicin	D.N.J.	2015-08-31	Terminated 2021-11-01	—

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

API Supply Chain3 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFIDAXOMICIN CRYSTALLINE

DMF 288032014

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDFIDAXOMICIN

DMF 293742015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFIDAXOMICIN

DMF 388152023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 14, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 16, 2024

No patent or exclusivity listings for this strength.