➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Mallinckrodt
Colorcon
Johnson and Johnson
Boehringer Ingelheim

Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Carfilzomib - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for carfilzomib and what is the scope of patent protection?

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.

Summary for carfilzomib
International Patents:221
US Patents:11
Tradenames:2
Applicants:3
NDAs:4
Drug Master File Entries: 10
Bulk Api Vendors: 67
Clinical Trials: 189
Patent Applications: 6,630
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
Karyopharm Therapeutics IncPhase 2
Hackensack Meridian HealthPhase 2
Førde Central HospitalPhase 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 202714-003 Jun 7, 2018 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 Y Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   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 C20160008 00189 Estonia   Start Trial PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
1781688 C01781688/01 Switzerland   Start Trial PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015
1781688 93015 Luxembourg   Start 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

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

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Dow
Harvard Business School
Moodys
Medtronic

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.