FDA Orange Book
Generic for Kyprolis
Kyprolis contains carfilzomib. 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
Yes. The generic name for Kyprolis is carfilzomib. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Kyprolis products the Orange Book lists.
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Kyprolis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 10MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 30MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 60MG/VIAL | Marketed (Rx) | AP | 2 | AP |
NDA 202714, held by ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carfilzomib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 209422 | AP (A-rated, therapeutically equivalent) | September 9, 2019 | 60MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 209526 | AP (A-rated, therapeutically equivalent) | July 20, 2026 | 60MG/VIAL |
Kyprolis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7417042 | July 20, 2026 | Drug substance, Drug product | None | 202714 |
| 7417042*PED | January 20, 2027 | Method of use | None | 202714 |
| 7737112 | December 7, 2027 | Drug product | None | 202714 |
| 7737112*PED | June 7, 2028 | Method of use | None | 202714 |
| RE47954 | October 21, 2029 | Method of use | U-3449 | 202714 |
| RE47954*PED | April 21, 2030 | Method of use | None | 202714 |
| 9493582 | February 27, 2033 | Drug product | None | 202714 |
| 9493582*PED | August 27, 2033 | Method of use | None | 202714 |
| 12636340 | April 29, 2041 | Method of use | U-4551 | 202714 |
| 12636340*PED | October 29, 2041 | Method of use | None | 202714 |
Kyprolis exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | May 22, 2028 | 202714 |
| PED | Pediatric exclusivity | November 22, 2028 | 202714 |
Kyprolis NDC codes
Questions
Is there a generic for Kyprolis?
Yes. The generic name for Kyprolis is carfilzomib. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Kyprolis products the Orange Book lists.
What is the generic name for Kyprolis?
The active ingredient in Kyprolis is carfilzomib, per the FDA Orange Book.
When does the Kyprolis patent expire?
The last patent listed for Kyprolis in the Orange Book expires October 29, 2041. 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.