Is there a generic for Gemifloxacin mesylate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Gemifloxacin mesylate, referencing the brand FACTIVE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Gemifloxacin mesylate?

FACTIVE (NDA 021158, LG CHEM LTD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gemifloxacin mesylate are approved?

Gemifloxacin mesylate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Gemifloxacin mesylate

Gemifloxacin mesylate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FACTIVE · NDA 021158

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
FACTIVERLD	LG CHEM LTD	NDA 021158	—	Apr 04, 2003

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
GEMIFLOXACIN MESYLATE	ORBION PHARMS	ANDA 090466	—	Jun 15, 2015

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Gemifloxacin mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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