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 eleven 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-one 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:	221
US Patents:	11
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	245
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
National Cancer Institute (NCI)	PHASE2
National Heart, Lung, and Blood Institute (NHLBI)	PHASE1
Washington University School of Medicine	PHASE1

See all CARFILZOMIB clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		60MG/VIAL	POWDER;INTRAVENOUS
		10MG/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	7,232,818		Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes	8,207,125		Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes	8,207,126		Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes	8,129,346
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes	9,493,582*PED				Y

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	7,491,704
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	8,207,126
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	7,232,818
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,207,297
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,129,346
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016	8,207,297

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
Hong Kong	1152536	用於抑制蛋白酶體的化合物 (COMPOUNDS FOR PROTEASOME ENZYM INHIBITION)
Japan	2014141456	COMPOUND FOR ENZYME INHIBITION
Japan	2007537265
South Korea	101299821
Mexico	353603	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)
Brazil	PI0509879	compostos para inibição enzimática

Supplementary Protection Certificates for CARFILZOMIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132016000047656	Italy		PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123
1781688	CR 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
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	SPC/GB16/022	United Kingdom		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123

Market Dynamics and Financial Trajectory for Carfilzomib

Last updated: July 28, 2025

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Introduction

Carfilzomib (brand name: Kyprolis), a selective proteasome inhibitor, has cemented its role in the treatment landscape of relapsed or refractory multiple myeloma (RRMM). Approved by the FDA in 2012, it offers a novel mechanism of action targeting proteasome pathways vital for cancer cell survival. As therapeutic options for multiple myeloma evolve, understanding the shifting market dynamics and financial outlook for carfilzomib becomes crucial for stakeholders, including pharmaceutical firms, investors, and healthcare providers.

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Market Landscape and Drivers

1. Expanding Indications and Evolving Labeling

Originally approved for patients who had received at least one prior therapy, recent developments have expanded carfilzomib's use. The FDA’s 2020 approval for earlier lines of treatment, including combination regimens with dexamethasone or other agents in newly diagnosed multiple myeloma (NDMM), positions it for broader adoption. This expansion directly influences the drug’s market size and demand, as the lines of therapy shift towards incorporating innovative agents earlier in disease management.

2. Competitive Dynamics

Carfilzomib contends primarily with other proteasome inhibitors, notably bortezomib and ixazomib, and with emerging agents such as marizomib and selective immunomodulators. The competitive landscape is characterized by:

• Efficacy and Safety Profiles: Carfilzomib’s superior efficacy in certain patient populations, especially those with high-risk cytogenetics, supports its premium positioning. Its safety profile, notably lower peripheral neuropathy, offers a benefit over bortezomib.
• Combination Therapies: Integration into combination regimens, such as with daratumumab or pomalidomide, enhances its therapeutic appeal and widens the market.
• Biosimilars and Generics: Patent expirations, anticipated around 2027, could introduce biosimilar competition, pressuring prices and profit margins.

3. Regulatory and Reimbursement Environment

The increasing approval of carfilzomib in various jurisdictions globally fosters market expansion. However, reimbursement policies and cost-effectiveness assessments influence uptake. In regions with stringent health technology assessment (HTA) processes, demonstrating value-added benefits over existing therapies remains essential for sustained market access.

4. Patient Demographics and Disease Burden

The global multiple myeloma burden is rising, particularly among aging populations in North America, Europe, and Asia-Pacific. Estimated global incidence surpasses 160,000 annually, with a median diagnosis age of 69. This demographic trend favors increased utilization of effective therapies like carfilzomib.

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Financial Trajectory and Revenue Outlook

1. Revenue Trends

Following its initial launch, carfilzomib experienced rapid growth driven by unmet medical needs and switching from prior therapies. Global sales peaked in 2021, with estimates exceeding USD 800 million (expected to vary based on source and market coverage). The compound annual growth rate (CAGR) from 2012 onwards reflects steady uptake, with quarterly sales reflecting the influence of drug approvals, reimbursement, and market penetration strategies.

2. Market Penetration Strategies

Pharmaceutical companies have targeted expansion through:

• Combination Regimens: Data demonstrating improved progression-free survival (PFS) and overall response rates (ORR) have fostered broader adoption.
• Geographical Expansion: Market entry in emerging economies, particularly China and India, offers high potential, considering the rising disease burden.
• Pricing and Access Initiatives: Tiered pricing models and patient assistance programs sustain accessibility while balancing revenue goals.

3. Pipeline and Developmental Outlook

The ongoing development of next-generation proteasome inhibitors, such as oprozomib and marizomib, could impact carfilzomib’s trajectory through competition. Yet, the existing evidence for combination therapies with novel agents (such as anti-CD38 monoclonal antibodies) suggests sustained relevance. Early-phase trials exploring subcutaneous formulations and reduced dosing schedules aim to improve tolerability and adherence, which could positively influence long-term sales.

4. Challenges and Risks

• Patents and Biosimilars: Patent expiration, projected around 2027, opens avenues for biosimilar entry, likely suppressing prices.
• Regulatory Scrutiny: Real-world safety concerns, especially related to cardiovascular events, may impact utilization and reimbursement.
• Market Saturation and Competition: The proliferation of new therapies, including CAR-T cell approaches and bispecific antibodies, could redefine the treatment paradigm and challenge proteasome inhibitors’ dominance.

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Future Outlook and Strategic Considerations

The financial journey of carfilzomib hinges on expanding indications, optimizing combination regimens, and navigating competitive and regulatory landscapes. The drug is poised for sustained growth through:

• Line-of-therapy Shift: As evidence supports earlier use, sales are expected to increase, especially if approved for frontline settings.
• Global Access: Penetration in emerging markets can unlock additional revenue streams.
• Innovative Delivery Formats: Subcutaneous formulations with favorable safety profiles will enhance patient compliance and marketability.
• Lifecycle Management: Strategic collaborations, label expansion, and pipeline integration will be instrumental in maintaining a competitive edge.

Stakeholders must monitor patent timelines, emerging clinical data, and shift in standard-of-care protocols to optimize financial planning and competitive positioning.

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Key Takeaways

• Carfilzomib’s evolving label and combination therapies bolster its market presence in multiple myeloma, with sales significantly influenced by broader indications and line-of-therapy shifts.
• Competitive pressures, including biosimilars and emerging therapies, pose risks to long-term revenue, emphasizing the importance of pipeline development and strategic marketing.
• Geographical expansion, especially into Asia-Pacific and other emerging markets, offers substantial growth potential, contingent on reimbursement policies.
• Enhancing formulations and gaining approval for earlier disease stages will drive sustained revenue growth.
• Monitoring patent expirations and biosimilar entries is vital for revenue forecasts and lifecycle management.

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FAQs

Q1: When is patent expiry expected for carfilzomib, and how will it impact the market?
Patent protection is anticipated to expire around 2027. This will likely result in biosimilar entries, increasing price competition and potentially reducing revenue margins temporarily, unless balanced by expanded indications and new formulations.

Q2: What are the primary factors influencing carfilzomib’s market growth?
Key drivers include its expanding approved indications, combination regimen efficacy, global disease burden, and increasing adoption in earlier treatment lines.

Q3: How does combination therapy influence carfilzomib’s market share?
Combination therapies with agents like daratumumab or lenalidomide have demonstrated superior efficacy, leading to wider adoption, especially in transplant-ineligible and high-risk patients, thus boosting market penetration.

Q4: What are the main challenges facing carfilzomib’s market sustainability?
Challenges include biosimilar competition post-patent expiry, reimbursement hurdles, safety concerns such as cardiovascular risks, and the emergence of newer treatment modalities like CAR-T therapies.

Q5: How are emerging markets affecting the financial trajectory of carfilzomib?
Growing healthcare infrastructure and increasing disease prevalence in emerging markets offer lucrative growth opportunities, provided pricing strategies are tailored to these regions.

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References

[1] U.S. Food and Drug Administration. Kyprolis (carfilzomib) approval history. 2012-2022.
[2] MarketWatch. Global multiple myeloma therapeutics market analysis. 2022.
[3] IMS Health. Proteasome inhibitor sales data. 2021.
[4] National Cancer Institute. Epidemiology of multiple myeloma. 2022.
[5] Evaluate Pharma. Oncology drug pipeline and forecast reports. 2022.