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KYPROLIS

NDA

CARFILZOMIB | N202714 | ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC

3 strengths5 unique patents3 unique exclusivities

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (4)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Apr. 21, 2030

Jan. 20, 2027

Jun. 7, 2028

Aug. 27, 2033

Oct. 29, 2041

M-14

Nov. 22, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

15 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Onyx Therapeutics, Inc. v. Amneal Pharmaceuticals of New York, LLC et al 1:2025cv01107 3 patentscarfilzomib	D. Del.	2025-09-04	Active	—
Onyx Therapeutics, Inc. v. Somerset Therapeutics, LLC 1:2025cv00500 3 patentsANDA 220194carfilzomib	D. Del.	2025-04-24	Terminated 2025-10-03	—
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc. 1:2019cv00071 3 patentsANDA 209330carfilzomib	D. Del.	2019-01-11	Terminated 2019-05-16	—
Onyx Therapeutics, Inc. v. CIPLA Limited et al 1:2018cv00598	D. Del.	2018-04-20	Terminated 2020-05-21	—
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc. 1:2018cv00262	D. Del.	2018-02-15	Terminated 2019-05-16	—
Onyx Therapeutics, Inc. v. Apotex Inc. et al 1:2018cv00132	D. Del.	2018-01-24	Terminated 2019-05-08	—
Onyx Therapeutics, Inc. v. MSN Pharmaceuticals, Inc. et al 1:2017cv01833 10 patentsANDA 209526carfilzomib	D. Del.	2017-12-20	Terminated 2019-05-08	—
Onyx Therapeutics, Inc. v. Dr. Reddys Laboratories, Inc et al. 1:2017cv01811 8 patentsANDA 209422carfilzomib	D. Del.	2017-12-18	Terminated 2019-05-16	—
Onyx Therapeutics, Inc. v. Aurobindo Pharma USA, Inc. 1:2017cv01699 9 patentsANDA 210823carfilzomib	D. Del.	2017-11-22	Terminated 2019-05-08	—
Onyx Therapeutics, Inc. v. Qilu Pharma, Inc. et al 1:2017cv01235	D. Del.	2017-08-30	Terminated 2018-02-07	—
Onyx Therapeutics, Inc. v. Apotex Inc. et al 1:2017cv01202	D. Del.	2017-08-24	Terminated 2019-05-08	—
Onyx Therapeutics, Inc. v. InnoPharma Inc. 1:2017cv01155	D. Del.	2017-08-17	Terminated 2019-05-08	—
Onyx Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. 1:2017cv00449 9 patentsANDA 210170carfilzomib	D. Del.	2017-04-20	Terminated 2018-02-14	—
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical Inc. 1:2016cv01001 9 patentsANDA 209330carfilzomib	D. Del.	2016-10-27	Terminated 2019-05-16	—
Onyx Therapeutics, Inc. v. CIPLA Limited et al 1:2016cv00988 9 patentsANDA 209479carfilzomib	D. Del.	2016-10-24	Terminated 2023-02-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Qilu Pharmaceutical Co., Ltd. FDA-2015-P-1590 · 4 docket documents Qilu Pharmaceutical Co., Ltd., through its US agent Qilu Pharma, Inc., submitted this suitability petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that new strengths of 10mg/vial and 30mg/vial of Carfilzomib for injection are suitable f	Suitability	2015-05-12	Denied	Qilu Pharmaceutical Co., Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

173 trials from ClinicalTrials.gov — 2 recruiting, 29 active, 98 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma NCT02415413	Phase 2	Active	PETHEMA Foundation	90	2015-05 → 2027-06
CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma NCT03798678	Phase 1	Active	National Cancer Institute (NCI)	36	2019-07-08 → 2026-09-11
Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant NCT03289299	Phase 2	Active	International Myeloma Foundation	87	2018-05-25 → 2031-11-15
Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma NCT02659293	Phase 3	Active	University of Chicago	180	2016-04-26 → 2027-11
Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia NCT04263480	Phase 2	Active	Christian Buske	99	2021-08-18 → 2028-05
Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA)NCT03729804	Phase 3	Active	University of Chicago	250	2019-05-07 → 2026-12-28
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients NCT03606577	Phase 2	Active	Nantes University Hospital	50	2019-07-30 → 2027-11-08
Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma NCT01863550	Phase 3	Active	ECOG-ACRIN Cancer Research Group	1,087	2013-12-06 → 2034-02-05
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.NCT03314636	Phase 2	Active	Oslo University Hospital	53	2018-03-16 → 2026-11-01
A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma NCT03290950	Phase 2	Active	Memorial Sloan Kettering Cancer Center	69	2017-09-25 → 2026-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$380.07

Highest Price

$3038.69

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
76075-0101-01KYPROLIS 60MG VIAL INJ	$3038.69	FSS	Amgen USA, Inc.	07/31/2026
76075-0101-01KYPROLIS 60MG VIAL INJ	$2284.32	Big4	Amgen USA, Inc.	07/31/2026
76075-0102-01KYPROLIS 30MG VIAL INJ	$1519.35	FSS	Amgen USA, Inc.	07/31/2026
76075-0102-01KYPROLIS 30MG VIAL INJ	$1145.03	Big4	Amgen USA, Inc.	07/31/2026
76075-0103-01KYPROLIS 10MG VIAL INJ	$506.44	FSS	Amgen USA, Inc.	07/31/2026
76075-0103-01KYPROLIS 10MG VIAL INJ	$380.07	Big4	Amgen USA, Inc.	07/31/2026
76075-0103-21KYPROLIS 10MG VIAL INJ	$506.44	FSS	Amgen USA, Inc.	07/31/2026
76075-0103-21KYPROLIS 10MG VIAL INJ	$380.07	Big4	Amgen USA, Inc.	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Kyprolis (2024)

Total Spending

$17.7M

Total Claims

1,643

Beneficiaries

211

Avg Cost/Unit

$2009.04

Spending Trend

$6.8M(2019)→$7.3M(2020)→$7.6M(2021)→$12.0M(2022)→$14.1M(2023)→$17.7M(2024)

YoY Change:+33.6%

5yr CAGR:+2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Kyprolis (2024)

Total Spending

$396.7M

Total Claims

79,659

Beneficiaries

5,806

ASP Price

$48.37

Spending Trend

$276.3M(2019)→$293.5M(2020)→$308.2M(2021)→$366.7M(2022)→$401.1M(2023)→$396.7M(2024)

YoY Change:+5.2%

5yr CAGR:+8.2%

HCPCS: J9047 — Injection, carfilzomib, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain20 active DMFs4 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDCARFILZOMIB [ROUTE CODE "CJ"]

DMF 296712015

QILU PHARMACEUTICAL CO LTDCARFILZOMIB (NON-STERILE, API)

DMF 297702015

LAURUS LABS LTDCARFILZOMIB

DMF 301152016

TAPI NL BVCARFILZOMIB

DMF 301242016

POLYMED THERAPEUTICS INCCARFILZOMIB DRUG SUBSTANCE

DMF 303572016

DR REDDYS LABORATORIES LTDCARFILZOMIB

DMF 304022016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCARFILZOMIB

DMF 324062017

INTAS PHARMACEUTICALS LTDCARFILZOMIB

DMF 350832020

CHONGQING CARELIFE PHARMACEUTICAL CO LTDCARFILZOMIB NON-STERILE BULK DRUG SUBSTANCE

DMF 381802023

SHANDONG NEW TIME PHARMACEUTICAL CO LTDCARFILZOMIB

DMF 382902023

JIANGSU XIDI PHARMACEUTICALS CO LTDCARFILZOMIB

DMF 384862023

HETERO LABS LTDCARFILZOMIB

DMF 402682025

SICHUAN HUIYU PHARMACEUTICAL CO LTDCARFILZOMIB

DMF 407582024

CHONGQING SINTAHO PHARMACEUTICAL CO LTDCARFILZOMIB

DMF 408912025

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDCARFILZOMIB, NON-STERILE, BULK DRUG SUBSTANCE

DMF 410292025

CHONGQING MIDECO PHARMACEUTICAL CO LTDCARFILZOMIB

DMF 411992025

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDCARFILZOMIB, NON-STERILE, BULK DRUG SUBSTANCE

DMF 412632025

TONGSHENG PHARMACEUTICAL (JINGMEN) CO LTDCARFILZOMIB

DMF 424022025

TONGSHENG PHARMACEUTICAL (JINGMEN) CO LTDCARFILZOMIB INTERMEDIATE

DMF 428522025

WISDOM PHARMACEUTICAL CO LTDCARFILZOMIB

DMF 433722025

FRESENIUS KABI ONCOLOGY LTDInactiveCARFILZOMIB

DMF 297502016

CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDInactiveCARFILZOMIB (NON-STERILE BULK DRUG SUBSTANCE)

DMF 301622015

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveCARFILZOMIB

DMF 312762016

SEACROSS PHARMA USA INCInactiveCARFILZOMIB

DMF 381692023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
May 27, 2025	SUPPL -36	View Letter (PDF)
Jul 1, 2022	SUPPL -34	View Letter (PDF)
Dec 1, 2021	SUPPL -33	View Letter (PDF)
Mar 10, 2021	SUPPL -32	View Letter (PDF)
Aug 24, 2020	SUPPL -30	View Letter (PDF)
May 11, 2020	SUPPL -29	View Letter (PDF)
Oct 9, 2019	SUPPL -27	View Letter (PDF)
Mar 1, 2019	SUPPL -25	View Letter (PDF)
Oct 1, 2018	SUPPL -21	View Letter (PDF)
Jun 14, 2018	SUPPL -19	View Letter (PDF)
Jan 17, 2018	SUPPL -17	View Letter (PDF)
May 30, 2017	SUPPL -16	View Letter (PDF)
Nov 18, 2016	SUPPL -15	View Letter (PDF)
Aug 4, 2016	SUPPL -13	View Letter (PDF)
Jul 6, 2016	SUPPL -12	View Letter (PDF)
May 25, 2016	SUPPL -11	View Letter (PDF)
Jan 22, 2016	SUPPL -10	View Letter (PDF)
Jul 27, 2015	SUPPL -9	View Letter (PDF)
Apr 3, 2015	SUPPL -8	View Letter (PDF)
Jul 20, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 60MG/VIAL

RLDAP

5 patents3 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jul 20, 2012

Patents (5) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE47954	Oct 21, 2029PED: Apr 21, 2030	PED	—	—		—
7417042	Jul 20, 2026PED: Jan 20, 2027	PED	Yes	Yes	—	—
7737112	Dec 7, 2027PED: Jun 7, 2028	PED	—	Yes	—	—
9493582	Feb 27, 2033PED: Aug 27, 2033	PED	—	Yes	—	—
12636340Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Apr 29, 2041PED: Oct 29, 2041	PED	—	—		—

Exclusivities (3)

Code	Date	Status
M-14	May 22, 2028	Active
PED	Nov 22, 2028	Active
M-14*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Nov 22, 2028	Active

#002 — 30MG/VIAL

RLD

5 patents3 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 3, 2016

#003 — 10MG/VIAL

RLD

5 patents3 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 7, 2018

Change History (3)

Recent changes detected for this application.

ADDED7/14/2026

KYPROLIS (carfilzomib) received a pediatric exclusivity extension that will delay generic entry until Nov 2028.

New: KYPROLIS (CARFILZOMIB) — exclusivity M-14*PED exp 11/22/2028

ADDED7/14/2026

Pediatric exclusivity for Kyprolis (carfilzomib) extends the regulatory exclusivity expiration to Nov 2028.

New: KYPROLIS (CARFILZOMIB) — exclusivity M-14*PED exp 11/22/2028

ADDED7/14/2026

KYPROLIS (carfilzomib) gained pediatric exclusivity with an expiration date of Nov 2028 under application N202714.

New: KYPROLIS (CARFILZOMIB) — exclusivity M-14*PED exp 11/22/2028