Carfilzomib - Generic Drug Details

What are the generic drug 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 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 four tentative approvals for this compound.

Summary for carfilzomib

International Patents:	220
US Patents:	11
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	228
Patent Applications:	6,016
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
AbbVie	Phase 3
Pfizer	Phase 3
Hoffmann-La Roche	Phase 1/Phase 2

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
Breckenridge	CARFILZOMIB	carfilzomib	POWDER;INTRAVENOUS	209330-002	Jun 11, 2021		DISCN	No	No
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	No	8,207,125		Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No	7,417,042		Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No	RE47954
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes	7,737,112		Y

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/003790 Kyprolis 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
Poland	2261236
Japan	2007537265
New Zealand	603739	Combination therapy with peptide epoxyketones
China	101014612	Compounds for proteasome enzyme inhibition
Japan	2012506445

Supplementary Protection Certificates for carfilzomib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	12/2016	Austria		PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
1781688	300805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 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	SPC/GB16/022	United Kingdom		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123

Carfilzomib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carfilzomib

Market Overview

Carfilzomib, marketed under the brand name Kyprolis, is a potent proteasome inhibitor used primarily to treat multiple myeloma, a cancer affecting plasma cells. The drug works by blocking proteasomes, which are essential for protein degradation, thereby slowing the proliferation and spread of cancer cells[1].

Market Growth and Projections

The carfilzomib market is anticipated to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. This growth is driven by several key factors:

• Increasing Prevalence of Multiple Myeloma: The rising incidence of multiple myeloma globally is a major driver, as it increases the demand for effective treatments like carfilzomib[1].
• Advances in Cancer Treatment: Continuous advancements in cancer therapies and the clinical evidence supporting the efficacy and safety of carfilzomib contribute to market expansion[1].
• Regulatory Approvals: New indications and favorable regulatory environments expedite drug approvals, further boosting market growth[1].

Regional Market Analysis

North America

North America dominates the carfilzomib market, holding more than 48% of the market share. This dominance is attributed to the advanced healthcare infrastructure, high investments in research and development, and a favorable regulatory environment in the region[1].

Europe

Europe is the second-largest market for carfilzomib. The aging population and the subsequent rise in multiple myeloma cases, along with innovative therapies supported by reputable academic and research institutions, drive the demand for carfilzomib in this region[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Economic growth, increased accessibility and affordability of carfilzomib, and investments in healthcare infrastructure and technology are key factors contributing to this growth[1].

Key Market Players

The carfilzomib market is dominated by a few large companies, including:

• Amgen Inc: The primary developer and marketer of Kyprolis (carfilzomib)[2].
• Natco: Known for its generic and biosimilar products, including carfilzomib[1].
• Cayman Chemical: A company involved in the production and distribution of carfilzomib and other pharmaceuticals[1].
• Tecoland Corporation: Another significant player in the carfilzomib market[1].

Economic Value and Cost-Effectiveness

Carfilzomib has been demonstrated to be cost-effective in treating relapsed or refractory multiple myeloma. The Kyprolis Global Economic Model (K-GEM) showed that the combination of carfilzomib with lenalidomide and dexamethasone (KRd) is more cost-effective than lenalidomide and dexamethasone (Rd) alone. The incremental cost-effectiveness ratio was $107,250 per Quality-Adjusted Life Year (QALY), which is within the reasonable benchmarks for cancer treatments in the U.S. ($150,000-$300,000 per QALY)[2].

Clinical Evidence and Trials

The ASPIRE trial, a Phase 3 head-to-head study, evaluated carfilzomib in combination with lenalidomide and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed multiple myeloma. The trial showed that the KRd regimen resulted in a significant improvement in median progression-free survival (PFS) compared to Rd (26.3 months vs. 17.6 months)[2].

Another notable trial is the ENDEAVOR study, which compared carfilzomib directly with bortezomib (Velcade), another proteasome inhibitor, in patients with relapsed multiple myeloma. This study also demonstrated the superiority of carfilzomib in terms of PFS and overall survival[3].

Market Dynamics

Drivers

• Increasing Incidence of Multiple Myeloma: The growing number of cases of multiple myeloma globally drives the demand for effective treatments.
• Advancements in Healthcare: Improved healthcare infrastructure and investments in R&D are crucial for the adoption of carfilzomib.
• Regulatory Approvals: Favorable regulatory environments and new indications for carfilzomib enhance market growth[1].

Limitations

• Adverse Reactions: Carfilzomib can cause significant adverse reactions, including low blood cell counts, fatigue, nausea, and potential heart problems, which can limit its adoption[1].
• High Cost: The cost of carfilzomib, although justified by its effectiveness, can be a barrier to access in some regions[2].

Opportunities

• Expanding into New Markets: The growing healthcare infrastructure in the Asia Pacific region presents opportunities for market expansion.
• Research and Development: Continuous R&D can lead to new indications and improved formulations of carfilzomib[1].

Financial Trajectory

The financial trajectory of the carfilzomib market is positive, with projected growth driven by increasing demand and favorable market conditions.

• Revenue Projections: The market is expected to reach a significant value by 2034, with a steady CAGR from 2024 to 2034[1].
• Segment Analysis: The market is segmented by type of cancer, treatment type, distribution channel, and region. Each segment is expected to contribute to the overall growth, with the hospital segment anticipated to expand significantly[4].

Distribution Channels

The distribution of carfilzomib is primarily through:

• Hospital Pharmacies: This segment is expected to retain its position throughout the forecast period due to the nature of the treatment, which is often administered in a hospital setting[1].
• Retail Pharmacies: Although less common, retail pharmacies also play a role in the distribution of carfilzomib.
• Online Pharmacies: The rise of online pharmacies is expected to contribute to the accessibility of carfilzomib, especially in regions with advanced e-healthcare infrastructure[1].

Key Takeaways

• The carfilzomib market is driven by the increasing incidence of multiple myeloma and advancements in cancer treatment.
• North America dominates the market, followed by Europe and the Asia Pacific region.
• Carfilzomib has been shown to be cost-effective and clinically superior in several trials.
• The market is expected to grow significantly, driven by favorable regulatory environments and high R&D investments.

FAQs

Q: What is carfilzomib used for? A: Carfilzomib is used to treat multiple myeloma, a cancer affecting plasma cells, particularly in patients who have not responded to previous treatments or are experiencing recurrence[1].

Q: Which region dominates the carfilzomib market? A: North America dominates the carfilzomib market, holding more than 48% of the market share[1].

Q: What are the common adverse reactions associated with carfilzomib? A: Common adverse reactions include low blood cell counts, fatigue, nausea, and potential heart problems[1].

Q: Is carfilzomib cost-effective? A: Yes, carfilzomib has been demonstrated to be cost-effective, with an incremental cost-effectiveness ratio of $107,250 per QALY, which is within reasonable benchmarks for cancer treatments[2].

Q: What are the key market players in the carfilzomib market? A: Key players include Amgen Inc, Natco, Cayman Chemical, and Tecoland Corporation[1].

Sources

1. Market Overview: WeMarketresearch, "Carfilzomib Market Research Report 2024-2034"[1].
2. Economic Value: PR Newswire, "Kyprolis® (Carfilzomib) Demonstrates Economic Value In Relapsed or Refractory Multiple Myeloma"[2].
3. Clinical Trials: PR Newswire, "Phase 3 Head-to-Head ENDEAVOR Study Demonstrates Superiority of Kyprolis (Carfilzomib) Over Velcade (Bortezomib) in Patients With Relapsed Multiple Myeloma"[3].
4. Market Analysis: Cognitive Market Research, "Global Carfilzomib Market Report 2024 Edition"[4].