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Last Updated: March 3, 2024

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, 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 nineteen 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
Carl Ola Landgren, MD, PhDPhase 2
GlaxoSmithKlinePhase 2
Dong-A University HospitalPhase 2

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial60MG/VIALPOWDER;INTRAVENOUS
⤷  Try a Trial⤷  Try a Trial10MG/VIALPOWDER;INTRAVENOUS
⤷  Try a Trial⤷  Try a Trial60MGINJECTABLE;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
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Hong Kong 1151966 COMPOSITION FOR PROTEASOME INHIBITION ⤷  Try a Trial
Israel 214776 תרכובות מבוססות פפטיד (Peptide-based compounds) ⤷  Try a Trial
Mexico 368109 TERAPIA DE COMBINACION CON EPOXICETONAS PEPTIDICAS. (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for carfilzomib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 C20160008 00189 Estonia ⤷  Try a Trial PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
1781688 C01781688/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015
1781688 93015 Luxembourg ⤷  Try a Trial PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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