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
- AZURITYNDA 2183952025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML (30MG/ML) SOLUTION INTRAVENOUS Rx - - NANJING DELOVANDA 2175932025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML (30MG/ML) SOLUTION INTRAVENOUS Rx - - ANJESORLDBAUDAXNDA 2105832020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/ML (30MG/ML) SOLUTION INTRAVENOUS Discontinued - - QMIIZ ODTRLDTERSERANDA 21121020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued - 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued - - VIVLODEXRLDICEUTICA OPERATIONSNDA 20723320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued - 10MG CAPSULE ORAL Discontinued - - MELOXICAMRLDRSAVONDALE PHARMSNDA 0215302004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG/5ML SUSPENSION ORAL Rx - - MOBICRLDBOEHRINGER INGELHEIMNDA 02093820002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued -
Generic (ANDA) products (25)
Abbreviated applications
- MELOXICAMASCENT PHARMS INCANDA 21757920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMNOVITIUM PHARMAANDA 21139820212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB - MELOXICAMLUPINANDA 20948720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB - MELOXICAMNOVITIUM PHARMAANDA 07792820092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMUNICHEMANDA 07792720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMCR DOUBLE CRANEANDA 07803920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMYUNG SHIN PHARMANDA 07791820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMTAROANDA 07810220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMAUROBINDO PHARMAANDA 07800820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMRISINGANDA 07793120062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMCOREPHARMAANDA 07788220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMMYLANANDA 07793420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMAIPING PHARM INCANDA 07792020062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMCHARTWELL RXANDA 07793620062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMCIPLAANDA 07792920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMGLENMARK PHARMS LTDANDA 07793220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMIMPAX LABS INCANDA 07793020062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMLUPIN PHARMSANDA 07794420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMNATCO PHARMAANDA 07792320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMPURACAP PHARMANDA 07793820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - MELOXICAMROXANEANDA 07792520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMSUN PHARM INDS INCANDA 07793720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMTP ANDA HOLDINGSANDA 07793520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMZENNOVAANDA 07793320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Discontinued - 15MG TABLET ORAL Discontinued - - MELOXICAMZYDUS PHARMS USAANDA 07792120062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10709713 | in 3 yr 8 mo | U-2750 | |
| 11253478 | in 3 yr 8 mo | ProductU-3318 | |
| 9974746 | in 3 yr 8 mo | Product | |
| 8545879 | in 3 yr 11 mo | Product | |
| 9526734 | in 6 yr 6 mo | Product | |
| 9808468 | in 8 yr 7 mo | U-2165 | |
| 9649318 | in 8 yr 7 mo | Product | |
| 11458145 | in 12 yr 7 mo | U-3318 | |
| 10881663 | in 12 yr 7 mo | U-3038 | |
| 12059423 | in 13 yr 11 mo | SubstanceProduct | |
| 12263176 | in 15 yr | Product |
Approval history
FDA approval span
First approval
26 yr 11 mo ago
Most recent approval
1 yr 5 mo ago
Approvals span 2000โ2025 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
- 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.
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