FDA Orange Book · active-ingredient family
Ketorolac tromethamine
Ketorolac tromethamine is approved as 7 brand and 55 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SPRIX · NDA 022382
7
Brand (NDA)
55
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution/drops, spray, metered, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPRIXRLD | ZYLA | NDA 022382 | — | May 14, 2010 | |
| ACUVAILRLD | ABBVIE | NDA 022427 | — | Jul 22, 2009 | |
| ACULAR LSRLD | ABBVIE | NDA 021528 | — | May 30, 2003 | |
| ACULARRLD | ABBVIE | NDA 019700 | AT | Nov 09, 1992 | |
| TORADOLRLD | ROCHE PALO | NDA 019645 | — | Dec 20, 1991 | |
| TORADOLRLD×2 | ROCHE PALO | NDA 019698 | — | Nov 30, 1989 | |
| ACULAR PRESERVATIVE FREE | ALLERGAN | NDA 020811 | — | Nov 03, 1997 |
Generic (ANDA) products (55)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | CAPLIN | ANDA 218204 | AT | Mar 26, 2024 | |
| KETOROLAC TROMETHAMINE×2 | ASPIRO | ANDA 217166 | AP | Jun 20, 2023 | |
| KETOROLAC TROMETHAMINE×2 | CAPLIN | ANDA 217789 | AP | May 10, 2023 | |
| KETOROLAC TROMETHAMINE | BIONPHARMA | ANDA 216759 | AB | Feb 23, 2023 | |
| KETOROLAC TROMETHAMINE | LEADING | ANDA 215745 | AB | Feb 23, 2023 | |
| KETOROLAC TROMETHAMINE×2 | ALEMBIC | ANDA 214456 | AP | Nov 02, 2022 | |
| KETOROLAC TROMETHAMINE | ATNAHS PHARMA US | ANDA 216407 | — | Oct 21, 2022 | |
| KETOROLAC TROMETHAMINE | ZYDUS LIFESCIENCES | ANDA 217038 | AB | Oct 21, 2022 | |
| KETOROLAC TROMETHAMINE | HETERO LABS LTD III | ANDA 216651 | AB | Aug 25, 2022 | |
| KETOROLAC TROMETHAMINE | SENORES PHARMS | ANDA 215788 | AB | Mar 23, 2022 | |
| KETOROLAC TROMETHAMINE | EUGIA PHARMA | ANDA 205190 | — | Dec 03, 2020 | |
| KETOROLAC TROMETHAMINE×2 | EUGIA PHARMA | ANDA 212939 | — | Oct 20, 2020 | |
| KETOROLAC TROMETHAMINE | NEPHRON | ANDA 211445 | AP | Aug 20, 2020 | |
| KETOROLAC TROMETHAMINE | MICRO LABS LTD INDIA | ANDA 203410 | AT | Apr 05, 2019 | |
| KETOROLAC TROMETHAMINE | EUGIA PHARMA | ANDA 205191 | — | Nov 15, 2018 | |
| KETOROLAC TROMETHAMINE | CHARTWELL RX | ANDA 210616 | AB | Aug 16, 2018 | |
| KETOROLAC TROMETHAMINE×2 | BAXTER HLTHCARE CORP | ANDA 209900 | AP | Jul 25, 2018 | |
| KETOROLAC TROMETHAMINE×2 | GLAND | ANDA 204216 | AP | Nov 01, 2016 | |
| KETOROLAC TROMETHAMINE×2 | FRESENIUS KABI USA | ANDA 203242 | — | Oct 07, 2015 | |
| KETOROLAC TROMETHAMINE×2 | ONESOURCE SPECIALTY | ANDA 201155 | — | Aug 04, 2014 | |
| KETOROLAC TROMETHAMINE | EPIC PHARMA LLC | ANDA 203376 | — | Feb 10, 2014 | |
| KETOROLAC TROMETHAMINE×2 | SAGENT PHARMS INC | ANDA 091065 | AP | Nov 27, 2013 | |
| KETOROLAC TROMETHAMINE | APOTEX | ANDA 077308 | — | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | APOTEX | ANDA 076109 | AT | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | CHARTWELL RX | ANDA 078434 | — | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | EPIC PHARMA LLC | ANDA 078399 | — | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | SANDOZ | ANDA 078721 | — | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | SANDOZ | ANDA 076583 | AT | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE | SUN PHARM | ANDA 090017 | — | Nov 05, 2009 | |
| KETOROLAC TROMETHAMINE×2 | SUN PHARM | ANDA 078737 | — | Oct 06, 2008 | |
| KETOROLAC TROMETHAMINE×2 | LUITPOLD | ANDA 078145 | — | Jan 14, 2008 | |
| KETOROLAC TROMETHAMINE×2 | ONESOURCE SPECIALTY | ANDA 078299 | — | Jul 16, 2007 | |
| KETOROLAC TROMETHAMINE×2 | APOTEX | ANDA 077942 | AP | Mar 27, 2007 | |
| KETOROLAC TROMETHAMINE | WOCKHARDT BIO AG | ANDA 077943 | — | Mar 27, 2007 | |
| KETOROLAC TROMETHAMINE | APOTEX INC | ANDA 077201 | — | Oct 14, 2005 | |
| KETOROLAC TROMETHAMINE×2 | SANDOZ | ANDA 076271 | — | Oct 06, 2004 | |
| KETOROLAC TROMETHAMINE×2 | GLAND PHARMA LTD | ANDA 076722 | — | Jul 27, 2004 | |
| KETOROLAC TROMETHAMINE×2 | AMPHASTAR PHARM | ANDA 076209 | — | Jul 21, 2004 | |
| KETOROLAC TROMETHAMINE×2 | HIKMA | ANDA 075772 | AP | Jul 21, 2004 | |
| KETOROLAC TROMETHAMINE×2 | FRESENIUS KABI USA | ANDA 075784 | AP | Jan 11, 2002 | |
| KETOROLAC TROMETHAMINE | APOTEX INC | ANDA 075626 | — | Jul 24, 2001 | |
| KETOROLAC TROMETHAMINE×2 | BAXTER HLTHCARE CORP | ANDA 075631 | — | Jun 29, 2001 | |
| KETOROLAC TROMETHAMINE×2 | APOTHECON | ANDA 075348 | — | Nov 28, 2000 | |
| KETOROLAC TROMETHAMINE×2 | HIKMA | ANDA 075299 | — | Nov 03, 1999 | |
| KETOROLAC TROMETHAMINE×2 | BEDFORD | ANDA 075230 | — | Oct 25, 1999 | |
| KETOROLAC TROMETHAMINE | PLIVA | ANDA 075284 | — | Jun 23, 1999 | |
| KETOROLAC TROMETHAMINE×2 | HIKMA | ANDA 075222 | — | Apr 26, 1999 | |
| KETOROLAC TROMETHAMINE | HIKMA | ANDA 075228 | — | Apr 26, 1999 | |
| KETOROLAC TROMETHAMINE×2 | HOSPIRA | ANDA 074993 | — | Jan 27, 1999 | |
| KETOROLAC TROMETHAMINE | WATSON LABS | ANDA 074955 | — | Sep 19, 1997 | |
| KETOROLAC TROMETHAMINE | CHARTWELL RX | ANDA 074790 | — | Jun 26, 1997 | |
| KETOROLAC TROMETHAMINE×2 | HOSPIRA | ANDA 074801 | — | Jun 05, 1997 | |
| KETOROLAC TROMETHAMINE×2 | HOSPIRA | ANDA 074802 | AP | Jun 05, 1997 | |
| KETOROLAC TROMETHAMINE | MYLAN | ANDA 074761 | AB | May 16, 1997 | |
| KETOROLAC TROMETHAMINE | TEVA | ANDA 074754 | AB | May 16, 1997 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8008338 | May 24, 2027 | in 11 mo | SubstanceProductU-1181 |
| 8008338*PED | Nov 24, 2027 | in 1 yr 5 mo | |
| 8512717 | Mar 07, 2028 | in 1 yr 9 mo | Product |
| 9192571 | Mar 07, 2028 | in 1 yr 9 mo | Product |
| 7842714 | Aug 15, 2029 | in 3 yr 2 mo | SubstanceProduct |
Ketorolac tromethamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
