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Last Updated: January 18, 2021

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Carfilzomib - Generic Drug Details

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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, Dr Reddys, and Onyx Therap, and is included in four 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-one patent family members in forty-one countries.

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

Recent Clinical Trials for carfilzomib

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

SponsorPhase
Sorlandet Hospital HFPhase 2/Phase 3
Førde Central HospitalPhase 2/Phase 3
The Hospital of VestfoldPhase 2/Phase 3

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG/VIALPOWDER;INTRAVENOUS
  Start Trial  Start TrialUNKNOWNUNKNOWN

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 NDA Submissiondate
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2018-11-28
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2017-10-05
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 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 202714-002 Jun 3, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for carfilzomib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 C 2016 014 Romania   Start Trial 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 12/2016 Austria   Start Trial PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
1781688 CA 2016 00014 Denmark   Start Trial PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 300805 Netherlands   Start Trial PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688 PA2016010 Lithuania   Start Trial PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 132016000047656 Italy   Start Trial PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123
1781688 PA2016010,C1781688 Lithuania   Start Trial PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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