FDA Orange Book · active-ingredient family
Indomethacin
Indomethacin is approved as 12 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TIVORBEX · NDA 204768
12
Brand (NDA)
59
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, injectable, suppository, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIVORBEXRLD×2 | GENUS | NDA 204768 | — | Feb 24, 2014 | |
| INDOMETHACINRLD | FRESENIUS KABI USA | NDA 022536 | — | Mar 17, 2010 | |
| INDOCINRLD | ZYLA | NDA 018332 | AB | Oct 10, 1985 | |
| INDOCINRLD | ZYLA LIFE SCIENCES | NDA 017814 | — | Aug 13, 1984 | |
| INDOCIN SRRLD | ZYLA | NDA 018185 | — | Feb 23, 1982 | |
| INDOCINRLD×2 | ZYLA LIFE SCIENCES | NDA 016059 | — | Approved Prior to Jan 1, 1982 | |
| INDOMETHACIN×2 | PARKE DAVIS | NDA 018806 | — | Nov 23, 1984 | |
| INDOMETHACIN×2 | CHARTWELL MOLECULES | NDA 018829 | AB | Aug 06, 1984 | |
| INDOMETHACIN×2 | WATSON LABS | NDA 018690 | — | Jul 31, 1984 | |
| INDOMETHACIN×2 | HERITAGE | NDA 018851 | — | May 18, 1984 | |
| INDOMETHACIN×2 | IVAX SUB TEVA PHARMS | NDA 018730 | — | May 04, 1984 | |
| INDOMETHACIN×2 | RISING | NDA 018858 | — | Apr 20, 1984 |
Generic (ANDA) products (59)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INDOMETHACIN | ANNORA PHARMA | ANDA 216905 | AB | Jul 03, 2025 | |
| INDOMETHACIN | AMNEAL | ANDA 215399 | AB | Feb 24, 2025 | |
| INDOMETHACIN | HIKMA | ANDA 215899 | AB | Nov 19, 2024 | |
| INDOMETHACIN | NOVITIUM PHARMA | ANDA 217883 | AB | Jan 12, 2024 | |
| INDOMETHACIN | ZYDUS LIFESCIENCES | ANDA 216184 | AB | Aug 02, 2023 | |
| INDOMETHACIN | ZYDUS PHARMS | ANDA 202711 | AB | Sep 25, 2017 | |
| INDOMETHACIN×2 | JUBILANT GENERICS | ANDA 205215 | — | Aug 25, 2017 | |
| INDOMETHACIN | GLENMARK PHARMS LTD | ANDA 203501 | AB | Jun 22, 2017 | |
| INDOMETHACIN | NOVAST LABS | ANDA 204853 | AB | May 08, 2017 | |
| INDOMETHACIN | AUROBINDO PHARMA | ANDA 204243 | — | Dec 27, 2016 | |
| INDOMETHACIN | JUBILANT GENERICS | ANDA 202706 | — | Oct 05, 2015 | |
| INDOMETHACIN | MYLAN | ANDA 202139 | — | Mar 20, 2014 | |
| INDOMETHACIN | WATSON LABS INC | ANDA 202572 | — | Dec 09, 2013 | |
| INDOMETHACIN×2 | SUN PHARM INDS INC | ANDA 091401 | — | Mar 28, 2013 | |
| INDOMETHACIN | HETERO LABS LTD III | ANDA 201807 | AB | Sep 28, 2012 | |
| INDOMETHACIN×2 | HETERO LABS LTD III | ANDA 091240 | AB | Apr 12, 2011 | |
| INDOMETHACIN×2 | GLENMARK PHARMS LTD | ANDA 091276 | AB | Dec 22, 2010 | |
| INDOMETHACIN | AMNEAL PHARMS | ANDA 091549 | AB | Dec 01, 2010 | |
| INDOMETHACIN | CHARTWELL RX | ANDA 200529 | AB | Nov 30, 2010 | |
| INDOMETHACIN×2 | ZYDUS LIFESCIENCES | ANDA 090403 | AB | Nov 15, 2010 | |
| INDOMETHACIN | AVANTHI INC | ANDA 079175 | AB | Mar 06, 2009 | |
| INDOMETHACIN×2 | ABLE | ANDA 076666 | — | Dec 17, 2003 | |
| INDOMETHACIN | ABLE | ANDA 076114 | — | Feb 06, 2002 | |
| INDOMETHACIN | SANDOZ | ANDA 074464 | — | May 28, 1998 | |
| INDOMETHACIN | COSETTE | ANDA 073314 | AB | Aug 31, 1992 | |
| INDOMETHACIN | WATSON LABS | ANDA 072996 | — | Jul 31, 1991 | |
| INDOMETHACIN | WATSON LABS | ANDA 072997 | — | Jul 31, 1991 | |
| INDOMETHACIN | INWOOD LABS | ANDA 072410 | — | Mar 15, 1989 | |
| INDOMETHACIN | TEVA | ANDA 071342 | — | Apr 18, 1988 | |
| INDOMETHACIN | TEVA | ANDA 071343 | — | Apr 18, 1988 | |
| INDOMETHACIN | HALSEY | ANDA 070782 | — | Jun 03, 1987 | |
| INDOMETHACIN | HALSEY | ANDA 070635 | — | Jun 03, 1987 | |
| INDOMETHACIN | WATSON LABS | ANDA 071635 | — | May 18, 1987 | |
| INDOMETHACIN | SANDOZ | ANDA 070673 | AB | Apr 29, 1987 | |
| INDOMETHACIN | SANDOZ | ANDA 070674 | AB | Apr 29, 1987 | |
| INDOMETHACIN | ANI PHARMS | ANDA 071148 | — | Mar 18, 1987 | |
| INDOMETHACIN | ANI PHARMS | ANDA 071149 | — | Mar 18, 1987 | |
| INDOMETHACIN | HIKMA | ANDA 071412 | — | Mar 18, 1987 | |
| INDOMETHACIN×2 | SUN PHARM INDUSTRIES | ANDA 070900 | — | Feb 09, 1987 | |
| INDOMETHACIN | SUPERPHARM | ANDA 070487 | — | Oct 10, 1986 | |
| INDOMETHACIN | SUPERPHARM | ANDA 070488 | — | Oct 10, 1986 | |
| INDOMETHACIN | MUTUAL PHARM | ANDA 070067 | — | Oct 03, 1986 | |
| INDOMETHACIN | MUTUAL PHARM | ANDA 070068 | — | Oct 03, 1986 | |
| INDOMETHACIN | WATSON LABS | ANDA 070784 | — | Aug 20, 1986 | |
| INDOMETHACIN | WATSON LABS | ANDA 070785 | — | Aug 20, 1986 | |
| INDOMETHACIN | PIONEER PHARMS | ANDA 070813 | — | Aug 11, 1986 | |
| INDOMETHACIN | PIONEER PHARMS | ANDA 070592 | — | Aug 11, 1986 | |
| INDOMETHACIN | CHARTWELL MOLECULES | ANDA 070651 | AB | Mar 05, 1986 | |
| INDOMETHACIN | HERITAGE PHARMA | ANDA 070719 | — | Feb 12, 1986 | |
| INDOMETHACIN | HERITAGE PHARMA | ANDA 070756 | — | Feb 12, 1986 | |
| INDO-LEMMON | TEVA | ANDA 070266 | — | Nov 07, 1985 | |
| INDO-LEMMON | TEVA | ANDA 070267 | — | Nov 07, 1985 | |
| INDOMETHACIN | DURAMED PHARMS BARR | ANDA 070326 | — | Oct 18, 1985 | |
| INDOMETHACIN | DURAMED PHARMS BARR | ANDA 070327 | — | Oct 18, 1985 | |
| INDOMETHACIN | WATSON LABS | ANDA 070529 | — | Oct 18, 1985 | |
| INDOMETHACIN | WATSON LABS | ANDA 070530 | — | Oct 18, 1985 | |
| INDOMETHACIN | RISING | ANDA 070624 | — | Sep 04, 1985 | |
| INDOMETHACIN | CYCLE | ANDA 070353 | — | Jun 18, 1985 | |
| INDOMETHACIN | CYCLE | ANDA 070354 | — | Jun 18, 1985 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9089471 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 8734847 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 8992982 | Apr 23, 2030 | in 3 yr 11 mo | Product |
Indomethacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
