CARFILZOMIB - Generic Drug Details

What are the generic sources for carfilzomib and what is the scope of freedom to operate?

Carfilzomib is the generic ingredient in two branded drugs marketed by Apotex, Breckenridge, Dr Reddys, and Onyx Pharms Amgen, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carfilzomib has two hundred and twenty patent family members in forty-two countries.

There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There are five tentative approvals for this compound.

Summary for CARFILZOMIB

International Patents:	220
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	248
Patent Applications:	6,746
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARFILZOMIB
What excipients (inactive ingredients) are in CARFILZOMIB?	CARFILZOMIB excipients list
DailyMed Link:	CARFILZOMIB at DailyMed

Recent Clinical Trials for CARFILZOMIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Bristol-Myers Squibb	PHASE2
Regeneron Pharmaceuticals	PHASE3

See all CARFILZOMIB clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		10MG/VIAL	POWDER;INTRAVENOUS
		60MG/VIAL	POWDER;INTRAVENOUS
		60MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CARFILZOMIB

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CARFILZOMIB

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CARFILZOMIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	2016-07-20

US Patents and Regulatory Information for CARFILZOMIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes	RE47954*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes	7,737,112*PED				Y
Apotex	CARFILZOMIB	carfilzomib	POWDER;INTRAVENOUS	211185-001	Mar 20, 2020		DISCN	No	No
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes	7,737,112*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes	RE47954*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes

Expired US Patents for CARFILZOMIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	7,232,818
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016	8,207,127
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	7,232,818
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016	7,232,818
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,207,125
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	8,207,127
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,207,126

EU/EMA Drug Approvals for CARFILZOMIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for CARFILZOMIB

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2564834	Composés pour l'inhibition d'une enzyme du protéasome (Compounds for Proteasome Enzyme Inhibition)
Montenegro	01133	KOMBINOVANA TERAPIJA SA PEPTIDNIM EPOKSIKETONIMA (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES)
China	101006098	Compounds for proteasome enzyme inhibition
Singapore	155187	COMPOUNDS FOR PROTEASOME ENZYME INHIBITION
Hong Kong	1097860	COMPOUNDS FOR PROTEASOME ENZYME INHIBITION
Slovenia	2030981
Portugal	3101026

Supplementary Protection Certificates for CARFILZOMIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	625	Finland
1781688	PA2016010,C1781688	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	C 2016 014	Romania		PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1781688	2016/013	Ireland		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	300805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123

CARFILZOMIB Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Carfilzomib?

Carfilzomib, marketed as Kyprolis by Amgen, is a proteasome inhibitor approved for relapsed or refractory multiple myeloma. It entered the market in 2012, directly competing with bortezomib, the first proteasome inhibitor. The drug's adoption depends on several factors:

• Regulatory Approvals: Carfilzomib has received approvals in the U.S., EU, Japan, and other regions, expanding its global reach.

• Clinical Efficacy: Demonstrates superior or comparable efficacy to bortezomib, especially in patients refractory to prior treatments.

• Safety Profile: Carries risks of cardiovascular events and renal toxicity, influencing prescribing patterns.

• Competitive Landscape: Faces competition from other emerging proteasome inhibitors (e.g., ixazomib) and immunotherapies (e.g., daratumumab).

• Market Penetration: Adoption is centralized in specialty centers, with increased usage in combination regimens.

• Pricing and Reimbursement: Prices in the U.S. range from approximately $16,000 to $18,000 per cycle; reimbursement policies influence access.

• Pipeline and Lifecycle Management: Amgen invests in investigational uses and combination therapies to expand indications.

How Has the Financial Trajectory Evolved?

Sales Performance

• Global sales reached approximately $900 million in 2022, according to IQVIA data.
• U.S. sales account for around 80% of revenue, reflecting high adoption in North American markets.
• Sales growth is steady, with a compound annual growth rate (CAGR) of approximately 10% from 2017 to 2022.

Market Share

• Estimated to hold 25-30% of the proteasome inhibitor market for multiple myeloma.
• Bortezomib maintains the largest share but is gradually declining with carfilzomib's increased acceptance.

Revenue Trends

• The initial launch showed rapid uptake, reaching $400 million by 2014.
• Market saturation slowed growth post-2016 but maintained stability through combination therapies.

Pricing Strategy

• Amgen maintains premium pricing, with price adjustments reflecting inflation and market competition.
• Cost-effectiveness analyses in certain markets impact wider reimbursement.

Future Revenue Potential

• Market analysts project revenues could reach $1.2 billion by 2025, assuming rising adoption and expanded indications.

What Are the Drivers and Challenges Affecting Financial Outlook?

Drivers

• Aging population and rising multiple myeloma incidence increase the eligible patient pool.
• Combination therapy studies show improved efficacy, encouraging broader use.
• Expanded label indications, including earlier treatment lines, could increase sales.

Challenges

• Safety concerns may limit use in certain populations, affecting growth.
• Competition from newer agents, such as CAR T-cell therapies (e.g., idecabtagene vicleucel), could impact market share.
• Pricing pressures and reimbursement constraints threaten profit margins.

Pipeline and Clinical Trials

• Investigations include use in solid tumors and earlier lines of therapy, which could diversify revenue streams.
• Positive trial outcomes could lead to label expansion, bolstering market potential.

Summarized Data Table

Aspect	Details
2022 Global Sales	~$900 million
North America Market Share	~80%
CAGR (2017–2022)	~10%
Estimated 2025 Revenue	~$1.2 billion
Approved Indications	Relapsed/refractory multiple myeloma
Price per Treatment Cycle	$16,000–$18,000
Key Competitors	Bortezomib, ixazomib, immunotherapies
Major Risks	Cardiovascular toxicity, market competition

Key Takeaways

Carfilzomib experiences steady growth driven by demand for effective multiple myeloma treatments, with sales expected to rise modestly over the next few years. Its market share remains significant but faces pressure from newer therapies and pricing constraints. Its future financial performance hinges on regulatory approvals for new indications and successful expansion into combination regimens.

FAQs

1. How does Carfilzomib compare to Bortezomib in efficacy?
Carfilzomib has demonstrated higher response rates and faster progression-free survival in some clinical trials, especially in patients refractory to bortezomib.

2. What are the key safety concerns with Carfilzomib?
Major issues include cardiovascular events, hypertension, and renal toxicity, which require monitoring and influence prescribing.

3. Are there new formulations or delivery methods?
Currently, Carfilzomib is administered intravenously. No approved oral formulations exist, but research is ongoing.

4. What pipeline developments could impact its market?
Investigations into earlier treatment lines, combinations, and off-label uses could expand its role.

5. How does Reimbursement affect Carfilzomib sales?
Reimbursement policies vary by region; in the U.S., Medicare and private insurers largely cover the drug, but cost-sharing can limit access.

---

Sources:
[1] IQVIA. "Pharmaceutical Market Data." 2022.
[2] Amgen. "Kyprolis Prescribing Information." 2022.
[3] EvaluatePharma. "Market Forecasts for Multiple Myeloma Drugs." 2022.