You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

CARFILZOMIB - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 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 twenty 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
AbbViePhase 3
PfizerPhase 3
Hoffmann-La RochePhase 1/Phase 2

See all CARFILZOMIB clinical trials

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up60MG/VIALPOWDER;INTRAVENOUS
⤷  Sign Up⤷  Sign Up10MG/VIALPOWDER;INTRAVENOUS
⤷  Sign Up⤷  Sign Up60MGINJECTABLE;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 202714-001 Jul 20, 2012 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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

Supplementary Protection Certificates for CARFILZOMIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 CR 2016 00014 Denmark ⤷  Sign Up PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 625 Finland ⤷  Sign Up
1781688 SPC/GB16/022 United Kingdom ⤷  Sign Up PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.