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FDA Orange Book ยท active-ingredient family

Meloxicam

Meloxicam: 7 brands, 25 generics; first approved Apr 13, 2000; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 25 ANDA applications approved.

Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
25
Listed patents
11
Next patent expiry
May 26, 2030
in 3 yr 8 mo

Brand (NDA) products

Originator applications
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  • XIFYRMRLDRS
    NDA 2183952025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    30MG/ML (30MG/ML)SOLUTIONINTRAVENOUSRx-
  • QAMZOVARLDRS
    NDA 2175932025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    30MG/ML (30MG/ML)SOLUTIONINTRAVENOUSRx-
  • NDA 2105832020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    30MG/ML (30MG/ML)SOLUTIONINTRAVENOUSDiscontinued-
  • NDA 21121020182 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLET, ORALLY DISINTEGRATINGORALDiscontinued-
    15MGTABLET, ORALLY DISINTEGRATINGORALDiscontinued-
  • NDA 20723320152 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5MGCAPSULEORALDiscontinued-
    10MGCAPSULEORALDiscontinued-
  • MELOXICAMRLDRS
    NDA 0215302004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MG/5MLSUSPENSIONORALRx-
  • NDA 02093820002 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-

Generic (ANDA) products (25)

Abbreviated applications
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  • MELOXICAM
    ANDA 21757920232 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 21139820212 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5MGCAPSULEORALRxAB
    10MGCAPSULEORALRxAB
  • MELOXICAM
    ANDA 20948720202 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5MGCAPSULEORALRxAB
    10MGCAPSULEORALRxAB
  • MELOXICAM
    ANDA 07792820092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07792720062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07803920062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07791820062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07810220062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07800820062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07793120062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07788220062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07793420062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07792020062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07793620062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07792920062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07793220062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07793020062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07794420062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07792320062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07793820062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB
  • MELOXICAM
    ANDA 07792520062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07793720062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07793520062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07793320062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALDiscontinued-
    15MGTABLETORALDiscontinued-
  • MELOXICAM
    ANDA 07792120062 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MGTABLETORALRxAB
    15MGTABLETORALRxAB

Patent & exclusivity timeline

Protection horizon
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202620282030203220342036203820402042TodayPatent 10709713: 2030-05-26Patent 10709713Patent 11253478: 2030-05-26Patent 11253478Patent 9974746: 2030-05-26Patent 9974746Patent 8545879: 2030-08-31Patent 8545879Patent 9526734: 2033-03-31Patent 9526734Patent 9808468: 2035-03-31Patent 9808468Patent 9649318: 2035-03-31Patent 9649318Patent 11458145: 2039-03-08Patent 11458145Patent 10881663: 2039-03-08Patent 10881663Patent 12059423: 2040-07-19Patent 12059423Patent 12263176: 2041-07-31Patent 12263176
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.
PatentExpiresInType
10709713in 3 yr 8 mo
U-2750
11253478in 3 yr 8 mo
ProductU-3318
9974746in 3 yr 8 mo
Product
8545879in 3 yr 11 mo
Product
9526734in 6 yr 6 mo
Product
9808468in 8 yr 7 mo
U-2165
9649318in 8 yr 7 mo
Product
11458145in 12 yr 7 mo
U-3318
10881663in 12 yr 7 mo
U-3038
12059423in 13 yr 11 mo
SubstanceProduct
12263176in 15 yr
Product

Approval history

FDA approval span
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First approval
26 yr 11 mo ago
Most recent approval
1 yr 5 mo ago

Approvals span 2000โ€“2025 across 32 FDA applications.

Brand (NDA) 722%
Generic (ANDA) 2578%

Meloxicam: 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

Assyro Intelligence

Ask anything about Meloxicam

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  • ClinicalTrials.gov
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  • Health Canada
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