Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Medtronic
Merck
AstraZeneca
McKinsey

Last Updated: June 29, 2022

Carfilzomib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

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 Therap, 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-three patent family members in forty-one countries.

There are ten drug master file entries for carfilzomib. There are three tentative approvals for this compound.

Summary for carfilzomib
International Patents:223
US Patents:11
Tradenames:2
Applicants:4
NDAs:5
Drug Master File Entries: 10
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 210
Patent Applications: 7,755
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

SponsorPhase
Regeneron PharmaceuticalsPhase 1
University of Colorado, DenverPhase 2
OHSU Knight Cancer InstitutePhase 2

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing60MG/VIALPOWDER;INTRAVENOUS
See Plans and PricingSee Plans and Pricing10MG/VIALPOWDER;INTRAVENOUS
See Plans and PricingSee Plans and Pricing60MG/VIALPOWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

International Patents for carfilzomib

Country Patent Number Title Estimated Expiration
Chile 2011000916 Uso de una combinacion de un inhibidor de proteasoma epoxicetona peptidica o una sal farmaceutica aceptable del mismo, y uno o mas de otros agentes terapeuticos para tratar el cancer. See Plans and Pricing
Australia 2005313975 Composition for proteasome inhibition See Plans and Pricing
Japan 2008509166 See Plans and Pricing
European Patent Office 3090737 THÉRAPIE DE COMBINAISON AVEC PEPTIDES D'ÉPOXYCÉTONES (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES) See Plans and Pricing
Slovenia 1781688 See Plans and Pricing
Japan 6081964 See Plans and Pricing
Australia 2005243140 Synthesis of amino acid keto-epoxides See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for carfilzomib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 C 2016 014 Romania See Plans and Pricing 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 CR 2016 00014 Denmark See Plans and Pricing PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 93015 Luxembourg See Plans and Pricing PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
1781688 1690013-6 Sweden See Plans and Pricing PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
1781688 362 5009-2016 Slovakia See Plans and Pricing PRODUCT NAME: KARFILZOMIB; NAT. REGISTRATION NO/DATE: EU1/15/1060 20151123; FIRST REGISTRATION: EU EU/1/15/1060 20151123
1781688 CA 2016 00014 Denmark See Plans and Pricing PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 C01781688/01 Switzerland See Plans and Pricing PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Dow
Mallinckrodt
McKinsey
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.