KYPROLIS Drug Patent Profile

Which patents cover Kyprolis, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9^th, 2019.

Summary for KYPROLIS

International Patents:	220
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS

Paragraph IV (Patent) Challenges for KYPROLIS

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 KYPROLIS

KYPROLIS is protected by four US patents and two FDA Regulatory Exclusivities.

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	202714-003	Jun 7, 2018		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes					Y

International Patents for KYPROLIS

When does loss-of-exclusivity occur for KYPROLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYPROLIS around the world.

Country	Patent Number	Title	Estimated Expiration
Montenegro	01133	KOMBINOVANA TERAPIJA SA PEPTIDNIM EPOKSIKETONIMA (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES)
Cyprus	1117244
Japan	2011148805	COMPOUNDS FOR PROTEASOME ENZYME INHIBITION
Canada	2565407	COMPOSES D'INHIBITION ENZYMATIQUE (COMPOUNDS FOR ENZYME INHIBITION)
Hong Kong	1107948	COMPOSITION FOR PROTEASOME INHIBITION
Lithuania	PA2016010
Colombia	6361942

Supplementary Protection Certificates for KYPROLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	300805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688	12/2016	Austria		PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
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
1781688	93015	Luxembourg		PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
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	625	Finland
1781688	2016/013	Ireland		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119

KYPROLIS: Market Landscape and Patent Expiration Analysis

Last updated: February 19, 2026

Kyprolis (carfilzomib) is a proteasome inhibitor used for the treatment of relapsed or refractory multiple myeloma. Its market performance and patent landscape are critical for assessing ongoing investment viability and future market competition.

What is the Current Market Status of Kyprolis?

Kyprolis is a significant therapy in the multiple myeloma market. It is approved by the U.S. Food and Drug Administration (FDA) for multiple indications in this patient population, including:

• Treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies including a proteasome inhibitor and an immunomodulatory agent.
• Treatment of patients with multiple myeloma who have received at least one prior therapy.

The drug is administered intravenously. Its efficacy in various lines of therapy has contributed to its market penetration. Global sales figures for Kyprolis have demonstrated consistent growth. In 2022, Amgen reported worldwide sales of Kyprolis of $3.1 billion [1]. This represents an increase from $2.9 billion in 2021 [1].

What is the Patent Protection Status for Kyprolis?

The patent portfolio for Kyprolis is complex, involving composition of matter patents, formulation patents, and method of use patents. The primary composition of matter patent for carfilzomib is expected to expire in the coming years, opening the door for generic competition.

• U.S. Patent No. 7,790,745: This patent, covering carfilzomib itself, has an expiration date of September 26, 2027 [2]. However, extensions and potential litigation can alter this effective date.
• Other Patents: Additional patents cover specific formulations, manufacturing processes, and methods of treatment. For instance, U.S. Patent No. 9,745,304, which expired in January 2024, related to a specific formulation [3].

The expiration of key patents, particularly the composition of matter patent, is a critical inflection point for the drug's lifecycle. This will enable the entry of generic versions of carfilzomib, which typically leads to significant price erosion and a shift in market share.

What is the Competitive Landscape for Kyprolis?

The multiple myeloma market is highly competitive, with several approved therapies and a robust pipeline of investigational drugs. Kyprolis competes with other proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and other novel agents.

Key competitors include:

• Velcade (bortezomib): Another proteasome inhibitor, which has faced generic competition for several years.
• Ninlaro (ixazomib): An orally administered proteasome inhibitor.
• Pomalyst (pomalidomide): An immunomodulatory drug.
• Revlimid (lenalidomide): A cornerstone therapy in multiple myeloma, facing imminent generic competition.
• Darzalex (daratumumab): A CD38-targeting monoclonal antibody.
• Sarclisa (isatuximab-irfc): Another CD38-targeting monoclonal antibody.

The competitive intensity is expected to increase with the advent of generics for Kyprolis, as well as ongoing advancements in therapeutic strategies, such as bispecific antibodies and CAR T-cell therapies.

What are the Key Market Drivers and Restraints?

Market Drivers:

• Increasing Incidence of Multiple Myeloma: Age is a primary risk factor, and an aging global population contributes to a higher incidence of the disease.
• Advances in Treatment Regimens: The use of Kyprolis in combination therapies, often with other novel agents, has improved patient outcomes and expanded its utility.
• Label Expansions: Approval for earlier lines of therapy or in combination with specific agents can significantly increase market potential.
• Unmet Needs in Relapsed/Refractory Settings: Despite advancements, a significant portion of patients with relapsed or refractory disease still require more effective treatment options.

Market Restraints:

• Patent Expiration and Generic Competition: The impending loss of market exclusivity is the most significant restraint, leading to price declines and market share erosion.
• High Cost of Treatment: Kyprolis is an expensive therapy, which can limit access for some patients and healthcare systems.
• Adverse Events: Like all cancer therapies, Kyprolis has a profile of adverse events that require careful patient management and can affect treatment adherence.
• Emergence of Novel Therapies: The rapid pace of innovation in oncology, particularly in hematologic malignancies, means that newer, potentially more effective, or convenient therapies can quickly challenge existing treatments.

What is the Projected Impact of Patent Expiration on Kyprolis Sales?

The expiration of the U.S. composition of matter patent for carfilzomib in September 2027 will initiate the period of significant market disruption. Historically, the introduction of generic versions of oncology drugs has led to rapid and substantial price reductions, typically ranging from 50% to 90% within the first year of generic entry [4].

• Sales Decline: Amgen's revenue from Kyprolis is expected to decline sharply following patent expiration. The magnitude and speed of this decline will depend on factors such as the number of generic manufacturers entering the market, the pricing strategies adopted by generic companies, and the contractual agreements between Amgen and its payors.
• Market Share Shift: A substantial portion of the patient market will likely transition to generic carfilzomib due to its lower cost. However, branded Kyprolis may retain a smaller share in certain niche markets or for specific patient populations, particularly if Amgen offers authorized generics or manages its pricing strategically.
• Impact on Research & Development: The revenue generated from Kyprolis has supported Amgen's R&D efforts. A significant decline in sales will necessitate strategic adjustments in R&D investment and portfolio prioritization.

The projected impact on sales is a direct consequence of generic price erosion. While Amgen may have other patents protecting specific formulations or methods of use, the core composition of matter patent's expiration is the primary driver of generic entry.

What are the Investment Considerations for Kyprolis Post-Patent Expiration?

For investors, the post-patent expiration phase of a drug like Kyprolis presents a different set of opportunities and risks compared to its peak exclusivity period.

Key Investment Considerations:

• Generic Carfilzomib Manufacturers: Companies that successfully develop and launch generic versions of carfilzomib stand to gain market share and revenue, albeit at lower profit margins than the innovator. The regulatory pathway for generic approval, manufacturing capabilities, and distribution networks are critical success factors.
• Amgen's Strategy: Amgen's post-expiration strategy will be crucial. This could include the development of next-generation therapies, strategic partnerships, lifecycle management of existing products, or aggressive cost management.
• Market Dynamics of Multiple Myeloma: The overall growth trajectory of the multiple myeloma market, driven by incidence rates and the development of new therapeutic classes, will influence the size of the market available for both branded and generic carfilzomib.
• Pricing Power and Reimbursement: The ability of generic manufacturers to secure favorable pricing and reimbursement from payers will directly impact their profitability and market penetration.
• Litigation Risk: Patent litigation is common in the pharmaceutical industry. Any ongoing or future litigation related to Kyprolis patents can create uncertainty and affect the timing of generic entry.

Investing in the branded product post-expiration is generally riskier due to anticipated revenue decline. Investment in generic manufacturers requires an assessment of their R&D pipeline, manufacturing scale, and market access strategies.

Key Takeaways

• Kyprolis generated $3.1 billion in sales in 2022, underscoring its significant market presence in multiple myeloma.
• The primary U.S. patent for carfilzomib expires on September 26, 2027, initiating a period of generic competition.
• The multiple myeloma market is highly competitive, with numerous existing and emerging therapies.
• Patent expiration is projected to lead to a substantial decline in Kyprolis sales due to generic price erosion.
• Investment opportunities exist in generic carfilzomib manufacturing and in companies adapting to evolving market dynamics.

FAQs

1. When will generic versions of Kyprolis become available in the U.S. market? Generic versions of Kyprolis are expected to become available following the expiration of the primary U.S. composition of matter patent on September 26, 2027. The exact timing of market entry can be influenced by regulatory approvals and potential patent litigation.
2. How will the price of carfilzomib change after patent expiration? Following patent expiration, the price of carfilzomib is expected to decrease significantly due to the introduction of multiple generic competitors. Historical trends suggest price reductions of 50% to 90% within the first year of generic availability.
3. What are the potential impacts of generic carfilzomib on Amgen's revenue? Amgen's revenue from Kyprolis is projected to decline substantially after the expiration of its key patents as market share shifts to lower-priced generic alternatives.
4. Are there any remaining patents that could extend Kyprolis's market exclusivity beyond 2027? While the composition of matter patent expires in 2027, Amgen may hold other patents related to specific formulations, manufacturing processes, or methods of use. However, these are less likely to prevent the entry of generic carfilzomib if the core active pharmaceutical ingredient patent has expired.
5. What are the key factors for a generic manufacturer to succeed in the carfilzomib market? Success for a generic manufacturer hinges on obtaining timely regulatory approval, establishing efficient and scalable manufacturing processes, securing favorable pricing and reimbursement from payers, and building a robust distribution network to compete effectively.

Citations

[1] Amgen Inc. (2023). 2022 Annual Report on Form 10-K. U.S. Securities and Exchange Commission. [2] U.S. Patent No. 7,790,745. (2010). Carbapenem derivative compounds and their preparation. [3] U.S. Patent No. 9,745,304. (2017). Formulations of proteasome inhibitors. [4] GlobalData. (2021). Pharma's Patent Cliff: The Cost of Losing Exclusivity. https://www.globaldata.com/store/report/pharma-patent-cliff-analysis/