FDA Orange Book · active-ingredient family
Indomethacin
Indomethacin: 12 brands, 59 generics; first approved Feb 23, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 59 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
12
Generics (ANDA)
59
Listed patents
3
Next patent expiry
Apr 23, 2030
in 3 yr 7 mo
Brand (NDA) products
Originator applications
- TIVORBEXRLDGENUSNDA 20476820142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 40MG CAPSULE ORAL Discontinued — - INDOMETHACINRLDRSFRESENIUS KABI USANDA 0225362010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/VIAL INJECTABLE INJECTION Rx — - COSETTENDA 0183321985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML SUSPENSION ORAL Rx AB - INDOCINRLDCOSETTENDA 0178141984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Discontinued — - INDOCIN SRRLDZYLANDA 0181851982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOCINRLDZYLA LIFE SCIENCESNDA 016059—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINPARKE DAVISNDA 01880619842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINCHARTWELL MOLECULESNDA 01882919842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - INDOMETHACINWATSON LABSNDA 01869019842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINHERITAGENDA 01885119842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINIVAX SUB TEVA PHARMSNDA 01873019842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINRISINGNDA 01885819842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (59)
Abbreviated applications
- INDOMETHACINANNORA PHARMAANDA 2169052025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Rx AB - INDOMETHACINAMNEALANDA 2153992025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Rx AB - INDOMETHACINHIKMAANDA 2158992024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Rx AB - INDOMETHACINNOVITIUM PHARMAANDA 2178832024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML SUSPENSION ORAL Rx AB - INDOMETHACINZYDUS LIFESCIENCESANDA 2161842023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Rx AB - INDOMETHACINZYDUS PHARMSANDA 2027112017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINJUBILANT GENERICSANDA 20521520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINGLENMARK PHARMS LTDANDA 2035012017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINNOVAST LABSANDA 2048532017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINAUROBINDO PHARMAANDA 2042432016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINJUBILANT GENERICSANDA 2027062015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINMYLANANDA 2021392014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINWATSON LABS INCANDA 2025722013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINSUN PHARM INDS INCANDA 09140120132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINRSHETERO LABS LTD IIIANDA 2018072012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINHETERO LABS LTD IIIANDA 09124020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - INDOMETHACINGLENMARK PHARMS LTDANDA 09127620102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - INDOMETHACINAMNEAL PHARMSANDA 0915492010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINCHARTWELL RXANDA 2005292010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINZYDUS LIFESCIENCESANDA 09040320102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - INDOMETHACINAVANTHI INCANDA 0791752009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - INDOMETHACINABLEANDA 07666620032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - INDOMETHACINABLEANDA 0761142002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINSANDOZANDA 0744641998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINRSCOSETTEANDA 0733141992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG SUPPOSITORY RECTAL Rx AB - INDOMETHACINWATSON LABSANDA 0729961991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0729971991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACININWOOD LABSANDA 0724101989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - INDOMETHACINTEVAANDA 0713421988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINTEVAANDA 0713431988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINHALSEYANDA 0707821987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINHALSEYANDA 0706351987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0716351987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINSANDOZANDA 0706731987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - INDOMETHACINSANDOZANDA 0706741987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB - INDOMETHACINANI PHARMSANDA 0711481987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINANI PHARMSANDA 0711491987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINHIKMAANDA 0714121987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML SUSPENSION ORAL Discontinued — - INDOMETHACINSUN PHARM INDUSTRIESANDA 07090019872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — - INDOMETHACINSUPERPHARMANDA 0704871986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINSUPERPHARMANDA 0704881986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINMUTUAL PHARMANDA 0700671986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINMUTUAL PHARMANDA 0700681986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0707841986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0707851986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINPIONEER PHARMSANDA 0708131986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINPIONEER PHARMSANDA 0705921986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINCHARTWELL MOLECULESANDA 0706511986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB - INDOMETHACINHERITAGE PHARMAANDA 0707191986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINHERITAGE PHARMAANDA 0707561986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - TEVAANDA 0702661985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - TEVAANDA 0702671985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINDURAMED PHARMS BARRANDA 0703261985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINDURAMED PHARMS BARRANDA 0703271985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0705291985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINWATSON LABSANDA 0705301985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINRISINGANDA 0706241985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — - INDOMETHACINCYCLEANDA 0703531985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - INDOMETHACINCYCLEANDA 0703541985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9089471 | in 3 yr 7 mo | U-55 | |
| 8734847 | in 3 yr 7 mo | Product | |
| 8992982 | in 3 yr 7 mo | Product |
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1982–2025 across 71 FDA applications.
Brand (NDA) 1217%
Generic (ANDA) 5983%
Indomethacin: 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.
