FDA Orange Book
Is there a generic for Qinlock?
Qinlock contains ripretinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qinlock (ripretinib). The Orange Book shows its last listed patent expires October 6, 2042 and its last listed exclusivity ends May 15, 2027.
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Qinlock products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 213973, held by DECIPHERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qinlock patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8188113 | July 27, 2030 | Drug substance, Drug product | None | 213973 |
| RE48731 | June 7, 2032 | Method of use | U-3219 | 213973 |
| 8461179 | May 15, 2034 | Drug substance, Drug product | None | 213973 |
| 11426390 | August 12, 2040 | Method of use | U-3416 | 213973 |
| 12295944 | August 12, 2040 | Method of use | U-4183 | 213973 |
| 11433056 | August 12, 2040 | Method of use | U-3423 | 213973 |
| 12023327 | August 12, 2040 | Method of use | U-3958 | 213973 |
| 12023326 | August 12, 2040 | Method of use | U-3959 | 213973 |
| 12023325 | August 12, 2040 | Method of use | U-3960 | 213973 |
| 11529336 | August 12, 2040 | Method of use | U-3382 | 213973 |
| 11534432 | August 12, 2040 | Method of use | U-3442 | 213973 |
| 12318373 | August 12, 2040 | Method of use | U-4191 | 213973 |
| 11813251 | August 12, 2040 | Method of use | U-3750 | 213973 |
| 11344536 | August 12, 2040 | Method of use | U-3381 | 213973 |
| 11266635 | August 12, 2040 | Method of use | U-3330 | 213973 |
| 11576904 | August 12, 2040 | Method of use | U-3537 | 213973 |
| 10966966 | August 12, 2040 | Method of use | U-3153 | 213973 |
| 12059411 | August 12, 2040 | Method of use | U-3971 | 213973 |
| 12059410 | August 12, 2040 | Method of use | U-3153 | 213973 |
| 12023328 | December 30, 2040 | Method of use | U-3957 | 213973 |
| 11969415 | December 30, 2040 | Method of use | U-3219 | 213973 |
| 12064422 | December 30, 2040 | Method of use | U-3219 | 213973 |
| 11801237 | December 30, 2040 | Drug product | U-3219 | 213973 |
| 12708617 | December 30, 2040 | Method of use | U-3219 | 213973 |
| 11918564 | December 30, 2040 | Drug product | None | 213973 |
| 12213967 | December 30, 2040 | Drug product | None | 213973 |
| 11896585 | December 30, 2040 | Drug product | None | 213973 |
| 12318374 | December 30, 2040 | Drug product | None | 213973 |
| 11576903 | December 30, 2040 | Drug product | None | 213973 |
| 11903933 | December 30, 2040 | Drug product | None | 213973 |
| 12226406 | December 30, 2040 | Drug product | None | 213973 |
| 11844788 | December 30, 2040 | Drug product | None | 213973 |
| 11850241 | December 30, 2040 | Drug product | None | 213973 |
| 11395818 | December 30, 2040 | Drug product | None | 213973 |
| 11612591 | December 30, 2040 | Drug product | None | 213973 |
| 11185535 | December 30, 2040 | Drug product | None | 213973 |
| 11793795 | December 30, 2040 | Drug product | None | 213973 |
| 12213968 | December 30, 2040 | Drug product | None | 213973 |
| 11850240 | December 30, 2040 | Drug product | None | 213973 |
| 11911370 | December 30, 2040 | Drug product | None | 213973 |
| 11969414 | February 8, 2041 | Method of use | U-3897 | 213973 |
| 11779572 | October 6, 2042 | Method of use | U-3714 | 213973 |
Qinlock exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-298 | Orphan drug exclusivity | May 15, 2027 | 213973 |
Qinlock NDC codes
Questions
Is there a generic for Qinlock?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qinlock (ripretinib). The Orange Book shows its last listed patent expires October 6, 2042 and its last listed exclusivity ends May 15, 2027.
What is the generic name for Qinlock?
The active ingredient in Qinlock is ripretinib, per the FDA Orange Book.
When does the Qinlock patent expire?
The last patent listed for Qinlock in the Orange Book expires October 6, 2042. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.