FDA Orange Book · active-ingredient family
Carfilzomib
Carfilzomib: 1 brand, 4 generics; first approved Jul 20, 2012; generic available.
Generic available6 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
10
Next patent expiry
Jul 20, 2026
1 mo ago
Brand (NDA) products
Originator applications
- ONYX PHARMS AMGENNDA 20271420183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/VIAL POWDER INTRAVENOUS Rx AP 30MG/VIAL POWDER INTRAVENOUS Rx — 10MG/VIAL POWDER INTRAVENOUS Rx —
Generic (ANDA) products (4)
Abbreviated applications
- CARFILZOMIBBRECKENRIDGEANDA 20933020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL POWDER INTRAVENOUS Discontinued — 60MG/VIAL POWDER INTRAVENOUS Discontinued — - CARFILZOMIBAPOTEXANDA 2111852020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/VIAL POWDER INTRAVENOUS Discontinued — - CARFILZOMIBAPOTEXANDA 2094252020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/VIAL POWDER INTRAVENOUS Discontinued — - CARFILZOMIBDR REDDYSANDA 2094222019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/VIAL POWDER INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 2 yr 3 mo
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 2 yr 3 mo
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 2 yr 3 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7417042 | 1 mo ago | SubstanceProduct | |
| 7417042*PED | in 5 mo | ||
| 7737112 | in 1 yr 4 mo | Product | |
| 7737112*PED | in 1 yr 10 mo | ||
| RE47954 | in 3 yr 2 mo | U-3449 | |
| RE47954*PED | in 3 yr 8 mo | ||
| 9493582 | in 6 yr 7 mo | Product | |
| 9493582*PED | in 7 yr 1 mo | ||
| 12636340 | in 14 yr 11 mo | U-4551 | |
| 12636340*PED | in 15 yr 5 mo |
Approval history
FDA approval span
First approval
14 yr 4 mo ago
Most recent approval
5 yr 3 mo ago
Approvals span 2012–2021 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Carfilzomib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
