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.
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 |
What a generic Carfilzomib would have to match
Forms and strengths
For injection: 10 mg, 30 mg and 60 mg as a white to off-white lyophilized cake or powder in single-dose vial for reconstitution. For injection: 10 mg, 30 mg or 60 mg lyophilized powder in single-dose vial for reconstitution. ( 3 )
How it is supplied
How Supplied Kyprolis (carfilzomib) for Injection is supplied as: An individually packaged single-dose vial containing 10 mg of carfilzomib as a white to off-white lyophilized cake or powder: NDC 76075-103-01, NDC 76075-103-21. An individually packaged single-dose vial containing 30 mg of carfilzomib as a white to off-white lyophilized cake or powder: NDC 76075-102-01, NDC 76075-102-21. An individually packaged single-dose vial containing 60 mg of carfilzomib as a white to off-white lyophilized cake or powder: NDC 76075-101-01, NDC 76075-101-21. Storage and Handling Unopened vials should be stored refrigerated 2°C to 8°C (36°F to 46°F). Retain in original package to protect from light.
Storage
Storage and Handling Unopened vials should be stored refrigerated 2°C to 8°C (36°F to 46°F). Retain in original package to protect from light.
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2025-06-18.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Exenatideprotection runs to February 2027
- Linaclotideprotection runs to February 2027
- Semaglutideprotection runs to March 2027
- Lanreotideprotection runs to March 2027
- Tirzepatideprotection runs to May 2027
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.
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 2026-11-01. 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.
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