Is there a generic for Moxifloxacin hydrochloride?

Yes. The FDA Orange Book lists 25 approved generic (ANDA) applications for Moxifloxacin hydrochloride, referencing the brand MOXIFLOXACIN HYDROCHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Moxifloxacin hydrochloride?

MOXIFLOXACIN HYDROCHLORIDE (NDA 205572, FRESENIUS KABI USA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Moxifloxacin hydrochloride?

The Orange Book lists 2 patents against Moxifloxacin hydrochloride products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Moxifloxacin hydrochloride are approved?

Moxifloxacin hydrochloride is approved in the following dosage forms: solution, solution/drops, tablet.

FDA Orange Book · active-ingredient family

Moxifloxacin hydrochloride

Moxifloxacin hydrochloride: 5 brands, 25 generics; first approved Dec 10, 1999; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 25 ANDA applications approved.

Earliest patent expiry May 29, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 29, 2029

in 2 yr 8 mo

Brand (NDA) products

Originator applications

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MOXIFLOXACIN HYDROCHLORIDERLDRS
FRESENIUS KABI USANDA 2055722015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) SOLUTION INTRAVENOUS Rx -
MOXEZARLD
HARROW EYENDA 0224282010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
VIGAMOXRLDRS
HARROW EYENDA 0215982003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERRLD
BAYER HLTHCARENDA 0212772001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG/250ML (1.6MG/ML) SOLUTION INTRAVENOUS Discontinued -
AVELOXRLD
BAYER HLTHCARENDA 0210851999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG/250ML (1.6MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (25)

Abbreviated applications

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MOXIFLOXACIN HYDROCHLORIDE
MACLEODS PHARMSANDA 2091432026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
FDC LTDANDA 2194752025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
MOXIFLOXACIN HYDROCHLORIDE
MANKIND PHARMAANDA 2179882025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
SOMERSET THERAPS LLCANDA 2096982024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
HETERO LABS LTD VANDA 2048362023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
UPSHER SMITH LABSANDA 2126162021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
GLANDANDA 2087782020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
PHARMOBEDIENTANDA 2064472020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
MOXIFLOXACIN HYDROCHLORIDE
ALEMBICANDA 2094692019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
SUNSHINEANDA 2062952018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
EPIC PHARMA LLCANDA 2029162017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
MOXIFLOXACIN HYDROCHLORIDE
EUGIA PHARMAANDA 2062422017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
MSNANDA 2086822017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
APOTEXANDA 0900802017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERRS
MYLAN LABS LTDANDA 2058332017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG/250ML (1.6MG/ML) SOLUTION INTRAVENOUS Rx -
MOXIFLOXACIN HYDROCHLORIDE
CHARTWELL RXANDA 2072852017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
CROSSMEDIKA SAANDA 2053482016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
NATCOANDA 2046352015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Discontinued -
MOXIFLOXACIN HYDROCHLORIDERS
LUPINANDA 2040792015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx -
MOXIFLOXACIN HYDROCHLORIDE
REGCON HOLDINGSANDA 2025252015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
LUPINANDA 2028672014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1
MOXIFLOXACIN HYDROCHLORIDE
TORRENTANDA 2001602014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Discontinued -
MOXIFLOXACIN HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 2026322014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDERS
DR REDDYSANDA 0769382014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
MOXIFLOXACIN HYDROCHLORIDE
TEVA PHARMS USAANDA 0774372014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG/250ML (1.6MG/ML)	SOLUTION	INTRAVENOUS	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9114168	May 29, 2029	in 2 yr 8 mo	Product
8450311	May 29, 2029	in 2 yr 8 mo	Product

Approval history

FDA approval span

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First approval

Dec 10, 1999

27 yr 3 mo ago

Most recent approval

Mar 02, 2026

8 mo ago

Approvals span 1999–2026 across 30 FDA applications.

Brand (NDA) 517%

Generic (ANDA) 2583%

Moxifloxacin hydrochloride: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Moxifloxacin hydrochloride

Key facts