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Last Updated: December 22, 2024

KYPROLIS Drug Patent Profile


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When do Kyprolis patents expire, 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 eleven 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 9th, 2019.

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Drug patent expirations by year for KYPROLIS
Drug Prices for KYPROLIS

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Recent Clinical Trials for KYPROLIS

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SponsorPhase
Wuhan Union Hospital, ChinaPhase 2
Dong-A University HospitalPhase 2
GlaxoSmithKlinePhase 2

See all KYPROLIS clinical trials

Pharmacology for KYPROLIS
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
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 twenty US patents.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes ⤷  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 202714-003 Jun 7, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  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 KYPROLIS

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

International Patents for KYPROLIS

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

Country Patent Number Title Estimated Expiration
Poland 2261236 ⤷  Subscribe
Japan 2007537265 ⤷  Subscribe
New Zealand 603739 Combination therapy with peptide epoxyketones ⤷  Subscribe
China 101014612 Compounds for proteasome enzyme inhibition ⤷  Subscribe
Japan 2012506445 ⤷  Subscribe
China 104704007 Alkylated cyclodextrin compositions and processes for preparing and using the same ⤷  Subscribe
Canada 2565407 COMPOSES D'INHIBITION ENZYMATIQUE (COMPOUNDS FOR ENZYME INHIBITION) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYPROLIS

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
1781688 SPC/GB16/022 United Kingdom ⤷  Subscribe PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123
1781688 16C0017 France ⤷  Subscribe PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688 PA2016010 Lithuania ⤷  Subscribe PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

KYPROLIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KYPROLIS

Introduction to KYPROLIS

KYPROLIS, also known as carfilzomib, is a proteasome inhibitor developed by Amgen for the treatment of multiple myeloma, a type of blood cancer. It has been a significant player in the multiple myeloma treatment market, with a unique profile that sets it apart from other drugs in its class.

Market Position and Competitors

KYPROLIS operates in a competitive landscape dominated by other proteasome inhibitors such as VELCADE (bortezomib) and NINLARO (ixazomib), as well as other multiple myeloma treatments like Revlimid and Darzalex.

  • Market Share: In the proteasome inhibitors market, KYPROLIS has been gaining traction. While VELCADE represented more than 54% of the overall volume in 2018, KYPROLIS is expected to register a CAGR of more than 10% in terms of revenue from 2019 to 2023 due to its superior efficacy and target affinity[1].
  • Competitive Dynamics: The market is highly competitive, with drugs like Revlimid and Darzalex also vying for market share. However, KYPROLIS has distinguished itself through its clinical program, which has focused on reducing the dosing and administration burden on patients[4].

Financial Performance

The financial trajectory of KYPROLIS has been marked by both successes and challenges.

  • Revenue Growth: Despite initial high expectations, KYPROLIS' sales have not always met forecasts. In the second quarter of 2018, KYPROLIS generated $263 million worldwide, which was far below the $2.4 billion and $3 billion peak sales predicted by some industry analysts[4].
  • CAGR and Market Size: However, KYPROLIS is projected to grow significantly, with a CAGR of more than 10% from 2019 to 2023. This growth is driven by its superior efficacy and the expanding patient pool[1].

Clinical Trials and Regulatory Approvals

Clinical trials and regulatory approvals have played a crucial role in shaping the market dynamics for KYPROLIS.

  • FDA Approvals: The FDA has granted priority review for Amgen's supplemental new drug application for the expanded labeling of KYPROLIS in relapsed multiple myeloma. This has helped in broadening the drug's indications and improving its market position[5].
  • Clinical Trial Outcomes: While KYPROLIS has shown promising results in many clinical trials, it has also faced setbacks. For example, a combination of KYPROLIS, melphalan, and prednisone failed to outperform a cocktail of melphalan, prednisone, and VELCADE in improving survival among previously untreated patients in a 2016 trial[4].

Patient and Physician Preferences

Patient and physician preferences are critical in determining the market success of KYPROLIS.

  • Dosing Convenience: KYPROLIS offers a more convenient dosing option compared to some of its competitors. Amgen has focused on generating data to reduce the dosing and administration burden on patients, which has been a positive aspect of the drug[4].
  • Adverse Events: KYPROLIS has been noted for having significantly fewer adverse events compared to other drugs like Revlimid. This lower incidence of adverse events can influence physician prescribing decisions and patient compliance[3].

Regional Market Performance

The performance of KYPROLIS varies across different regions.

  • North America: The North-American proteasome inhibitors market, which includes KYPROLIS, accounted for about 47% of the overall revenue in 2018. This is due to the growing prevalence of cancer indications such as multiple myeloma and non-Hodgkin’s lymphoma in this region[1].

Impact of Biosimilars

The emergence of biosimilars has posed a challenge to Amgen and other biotech companies.

  • Biosimilar Competition: Biosimilars makers, such as Mylan, have been targeting Amgen's older drugs like Neupogen and Neulasta with lower-priced alternatives. This competition could indirectly affect KYPROLIS sales as Amgen's overall revenue is impacted[4].

Future Outlook

The future outlook for KYPROLIS is promising, despite the current challenges.

  • Expanded Labeling: The FDA's priority review for expanded labeling of KYPROLIS in relapsed multiple myeloma is expected to boost its market position and sales[5].
  • Continuous Research: Amgen's ongoing efforts to generate additional data and improve the dosing and administration of KYPROLIS are likely to enhance its market performance and patient acceptance[4].

Key Takeaways

  • KYPROLIS is expected to register a CAGR of more than 10% from 2019 to 2023 due to its superior efficacy and target affinity.
  • The drug has faced challenges in meeting initial sales forecasts but continues to grow in the market.
  • Clinical trials and regulatory approvals have been crucial in shaping its market dynamics.
  • Patient and physician preferences, particularly regarding dosing convenience and adverse events, favor KYPROLIS.
  • The North-American market is a significant contributor to KYPROLIS' revenue.
  • The emergence of biosimilars poses a broader challenge to Amgen's revenue streams.

FAQs

What is KYPROLIS used for?

KYPROLIS (carfilzomib) is used for the treatment of multiple myeloma, a type of blood cancer.

How does KYPROLIS compare to other proteasome inhibitors?

KYPROLIS is expected to register a higher CAGR than other proteasome inhibitors like VELCADE and NINLARO due to its superior efficacy and target affinity[1].

What are the key advantages of KYPROLIS?

KYPROLIS offers a more convenient dosing option and has a lower incidence of adverse events compared to some of its competitors[3][4].

How has the FDA supported KYPROLIS?

The FDA has granted priority review for Amgen's supplemental new drug application for the expanded labeling of KYPROLIS in relapsed multiple myeloma[5].

What impact do biosimilars have on KYPROLIS sales?

Biosimilars targeting Amgen's older drugs could indirectly affect KYPROLIS sales by impacting Amgen's overall revenue streams[4].

Sources

  1. Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023 - Biospace
  2. Financial Analysis of Competitive Drugs with PharmaKB - PharmaKB
  3. Financial Analysis of Competitive Drugs with PharmaKB - PharmaKB
  4. Can Amgen's new-and-improved Kyprolis kick-start myeloma sales? - FiercePharma
  5. FDA Grants Priority Review For Amgen's Supplemental New Drug Application For Expanded Labeling Of Kyprolis (Carfilzomib) In Relapsed Multiple Myeloma - Biospace

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