FDA Orange Book
Is there a generic for Kisqali?
Kisqali contains ribociclib. 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 Kisqali (ribociclib). The Orange Book shows its last listed patent expires October 14, 2036 and its last listed exclusivity ends January 1, 2030.
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Kisqali products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209092, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kisqali patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8324225 | June 17, 2028 | Drug substance, Drug product | None | 209092 |
| 8324225*PED | December 17, 2028 | Method of use | None | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-2355 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-2356 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-1981 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-3999 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-3266 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-3265 | 209092 |
| 9416136 | August 20, 2029 | Method of use | U-3975 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-1981 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-2356 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-2355 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-3999 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-3265 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-3266 | 209092 |
| 8962630 | December 9, 2029 | Method of use | U-3975 | 209092 |
| 9416136*PED | February 20, 2030 | Method of use | None | 209092 |
| 8685980 | May 25, 2030 | Drug substance, Drug product | None | 209092 |
| 8962630*PED | June 9, 2030 | Method of use | None | 209092 |
| 8685980*PED | November 25, 2030 | Method of use | None | 209092 |
| 8415355 | March 13, 2031 | Drug substance, Drug product | None | 209092 |
| 8415355*PED | September 13, 2031 | Method of use | None | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-2355 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-2356 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-3999 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-1981 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-3975 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-3265 | 209092 |
| 9868739 | November 9, 2031 | Method of use | U-3266 | 209092 |
| 9193732 | November 9, 2031 | Drug substance, Drug product | None | 209092 |
| 9193732*PED | May 9, 2032 | Method of use | None | 209092 |
| 9868739*PED | May 9, 2032 | Method of use | None | 209092 |
| 12544379 | August 7, 2034 | Method of use | U-3975 | 209092 |
| 12544380 | August 7, 2034 | Method of use | U-4404 | 209092 |
| 12544380 | August 7, 2034 | Method of use | U-4405 | 209092 |
| 12544379*PED | February 7, 2035 | Method of use | None | 209092 |
| 12544380*PED | February 7, 2035 | Method of use | None | 209092 |
| 12064434 | April 14, 2036 | Drug product | None | 209092 |
| 12419894 | April 14, 2036 | Drug product | None | 209092 |
| 10799506 | April 14, 2036 | Drug product | None | 209092 |
| 10799506*PED | October 14, 2036 | Method of use | None | 209092 |
| 12064434*PED | October 14, 2036 | Method of use | None | 209092 |
| 12419894*PED | October 14, 2036 | Method of use | None | 209092 |
Kisqali exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-950 | New indication | September 17, 2027 | 209092 |
| PED | Pediatric exclusivity | March 17, 2028 | 209092 |
| M-14 | Miscellaneous | July 1, 2029 | 209092 |
| PED | Pediatric exclusivity | January 1, 2030 | 209092 |
Kisqali NDC codes
Questions
Is there a generic for Kisqali?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kisqali (ribociclib). The Orange Book shows its last listed patent expires October 14, 2036 and its last listed exclusivity ends January 1, 2030.
What is the generic name for Kisqali?
The active ingredient in Kisqali is ribociclib, per the FDA Orange Book.
When does the Kisqali patent expire?
The last patent listed for Kisqali in the Orange Book expires October 14, 2036. 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.