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Last Updated: December 22, 2024

CARFILZOMIB - Generic Drug Details


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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 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
Recent Clinical Trials for CARFILZOMIB

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

SponsorPhase
AbbViePhase 3
PfizerPhase 3
Hoffmann-La RochePhase 1/Phase 2

See all CARFILZOMIB clinical trials

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe10MG/VIALPOWDER;INTRAVENOUS
⤷  Subscribe⤷  Subscribe60MG/VIALPOWDER;INTRAVENOUS
⤷  Subscribe⤷  Subscribe60MGINJECTABLE;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 ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for CARFILZOMIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 132016000047656 Italy ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
1781688 300805 Netherlands ⤷  Subscribe 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 ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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].

More… ↓

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