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
Brands (NDA)
5
Generics (ANDA)
25
Listed patents
2
Next patent expiry
May 29, 2029
in 2 yr 8 mo
Brand (NDA) products
Originator applications
- MOXIFLOXACIN HYDROCHLORIDERLDRSFRESENIUS 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 — - MOXEZARLDHARROW EYENDA 0224282010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - HARROW EYENDA 0215982003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - BAYER HLTHCARENDA 0212772001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/250ML (1.6MG/ML) SOLUTION INTRAVENOUS Discontinued — - AVELOXRLDBAYER HLTHCARENDA 0210851999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (25)
Abbreviated applications
- MOXIFLOXACIN HYDROCHLORIDEMACLEODS PHARMSANDA 2091432026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDEFDC LTDANDA 2194752025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - MOXIFLOXACIN HYDROCHLORIDEMANKIND PHARMAANDA 2179882025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDESOMERSET 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 HYDROCHLORIDEHETERO LABS LTD VANDA 2048362023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDEUPSHER 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 HYDROCHLORIDEGLANDANDA 2087782020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDEPHARMOBEDIENTANDA 2064472020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - MOXIFLOXACIN HYDROCHLORIDEALEMBICANDA 2094692019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDESUNSHINEANDA 2062952018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDEEPIC PHARMA LLCANDA 2029162017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - MOXIFLOXACIN HYDROCHLORIDEEUGIA PHARMAANDA 2062422017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDEMSNANDA 2086822017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDEAPOTEXANDA 0900802017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - 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 HYDROCHLORIDECHARTWELL RXANDA 2072852017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDECROSSMEDIKA SAANDA 2053482016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDENATCOANDA 2046352015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — - MOXIFLOXACIN HYDROCHLORIDERSLUPINANDA 2040792015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx — - MOXIFLOXACIN HYDROCHLORIDEREGCON HOLDINGSANDA 2025252015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDELUPINANDA 2028672014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT1 - MOXIFLOXACIN HYDROCHLORIDETORRENTANDA 2001602014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — - MOXIFLOXACIN HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2026322014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDERSDR REDDYSANDA 0769382014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - MOXIFLOXACIN HYDROCHLORIDETEVA PHARMS USAANDA 0774372014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9114168 | in 2 yr 8 mo | Product | |
| 8450311 | in 2 yr 8 mo | Product |
Approval history
FDA approval span
First approval
27 yr 3 mo ago
Most recent approval
7 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
