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Last Updated: June 28, 2022

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 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 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 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
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 202714-003 Jun 7, 2018 RX Yes No See Plans and Pricing See Plans and Pricing 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 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
World Intellectual Property Organization (WIPO) 2013130666 See Plans and Pricing
South Korea 101544258 See Plans and Pricing
Mexico 353603 COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.) See Plans and Pricing
Portugal 2030981 See Plans and Pricing
Japan 6517725 See Plans and Pricing
Slovenia 2261236 See Plans and Pricing
Denmark 1781688 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 PA2016010,C1781688 Lithuania See Plans and Pricing PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 625 Finland See Plans and Pricing
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 300805 Netherlands See Plans and Pricing PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION 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 122016000032 Germany See Plans and Pricing PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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