FDA Orange Book · active-ingredient family
Ripretinib
Ripretinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:QINLOCK · NDA 213973
1
Brand (NDA)
0
Generics (ANDA)
41
Listed patents
1
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QINLOCKRLD | DECIPHERA PHARMS | NDA 213973 | — | May 15, 2020 |
Marketing exclusivity (1)
- ODE-298Orphan-drug exclusivity (7 years)
May 15, 2027
in 11 mo
Listed patents (41)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8188113 | Jul 27, 2030 | in 4 yr 2 mo | SubstanceProduct |
| RE48731 | Jun 07, 2032 | in 6 yr 1 mo | U-3219 |
| 8461179 | May 15, 2034 | in 8 yr | SubstanceProduct |
| 11426390 | Aug 12, 2040 | in 14 yr 4 mo | U-3416 |
| 12295944 | Aug 12, 2040 | in 14 yr 4 mo | U-4183 |
| 11433056 | Aug 12, 2040 | in 14 yr 4 mo | U-3423 |
| 12023327 | Aug 12, 2040 | in 14 yr 4 mo | U-3958 |
| 12023326 | Aug 12, 2040 | in 14 yr 4 mo | U-3959 |
| 12023325 | Aug 12, 2040 | in 14 yr 4 mo | U-3960 |
| 11529336 | Aug 12, 2040 | in 14 yr 4 mo | U-3382 |
| 11534432 | Aug 12, 2040 | in 14 yr 4 mo | U-3442 |
| 12318373 | Aug 12, 2040 | in 14 yr 4 mo | U-4191 |
| 11813251 | Aug 12, 2040 | in 14 yr 4 mo | U-3750 |
| 11344536 | Aug 12, 2040 | in 14 yr 4 mo | U-3381 |
| 11266635 | Aug 12, 2040 | in 14 yr 4 mo | U-3330 |
| 11576904 | Aug 12, 2040 | in 14 yr 4 mo | U-3537 |
| 10966966 | Aug 12, 2040 | in 14 yr 4 mo | U-3153 |
| 12059411 | Aug 12, 2040 | in 14 yr 4 mo | U-3971 |
| 12059410 | Aug 12, 2040 | in 14 yr 4 mo | U-3153 |
| 12023328 | Dec 30, 2040 | in 14 yr 9 mo | U-3957 |
| 11969415 | Dec 30, 2040 | in 14 yr 9 mo | U-3219 |
| 12064422 | Dec 30, 2040 | in 14 yr 9 mo | U-3219 |
| 11801237 | Dec 30, 2040 | in 14 yr 9 mo | ProductU-3219 |
| 11918564 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 12213967 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11896585 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 12318374 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11576903 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11903933 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 12226406 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11844788 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11850241 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11395818 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11612591 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11185535 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11793795 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 12213968 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11850240 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11911370 | Dec 30, 2040 | in 14 yr 9 mo | Product |
| 11969414 | Feb 08, 2041 | in 14 yr 10 mo | U-3897 |
| 11779572 | Oct 06, 2042 | in 16 yr 6 mo | U-3714 |
Ripretinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
