Home / Generic availability / Carfilzomib
When will generic Carfilzomib be available?
Based on the patents and exclusivity the FDA lists today, generic carfilzomib cannot be marketed in the United States before 2041-10-29, when the last listed protection expires. 6 generic applications already hold tentative FDA approval, meaning the FDA has judged them acceptable and they are waiting on these dates.
Generics already cleared and waiting
A tentative approval means the FDA has already judged the generic to meet its standards but cannot allow marketing yet.
- MSN tentative approval 2026, application ANDA209526
- AMNEAL PHARMS NY tentative approval 2026, application NDA220712
- HAINAN POLY PHARM. CO., LTD. tentative approval 2025, application ANDA219276
- EUGIA PHARMA tentative approval 2022, application ANDA210823
- BRECKENRIDGE tentative approval 2021, application ANDA209330
- QILU PHARM CO LTD tentative approval 2019, application ANDA209528
Patents listed with the FDA
10 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7417042 | 2026-07-20 | drug substance, drug product | KYPROLIS |
| 7417042*PED | 2027-01-20 | method of use | KYPROLIS |
| 7737112 | 2027-12-07 | drug product | KYPROLIS |
| 7737112*PED | 2028-06-07 | method of use | KYPROLIS |
| RE47954 | 2029-10-21 | method of use | KYPROLIS |
| RE47954*PED | 2030-04-21 | method of use | KYPROLIS |
| 9493582 | 2033-02-27 | drug product | KYPROLIS |
| 9493582*PED | 2033-08-27 | method of use | KYPROLIS |
| 12636340 | 2041-04-29 | method of use | KYPROLIS |
| 12636340*PED | 2041-10-29 | method of use | KYPROLIS |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| M-14 | 2028-05-22 | Exclusivity tied to a specific labelling or study change | KYPROLIS |
| PED | 2028-11-22 | Pediatric exclusivity (adds 6 months) | KYPROLIS |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| KYPROLIS | Brand (NDA) | ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC | 2012-07-20 | reference listed drug, reference standard |
| CARFILZOMIB | Generic (ANDA) | BRECKENRIDGE PHARMACEUTICAL INC | 2021-06-11 | |
| CARFILZOMIB | Generic (ANDA) | DR REDDYS LABORATORIES LTD | 2019-09-09 | |
| CARFILZOMIB | Generic (ANDA) | APOTEX INC | 2020-03-16 | |
| CARFILZOMIB | Generic (ANDA) | MSN LABORATORIES PRIVATE LTD | 2026-07-20 | |
| CARFILZOMIB | Generic (ANDA) | APOTEX INC | 2020-03-20 |
Frequently asked questions
When will generic Carfilzomib be available?
Based on the patents and exclusivity the FDA lists today, generic carfilzomib cannot be marketed in the United States before 2041-10-29, when the last listed protection expires. 6 generic applications already hold tentative FDA approval, meaning the FDA has judged them acceptable and they are waiting on these dates.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.