CARFILZOMIB - Generic Drug Details
✉ Email this page to a colleague
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
Sponsor | Phase |
---|---|
Regeneron Pharmaceuticals | Phase 1 |
University of Colorado, Denver | Phase 2 |
OHSU Knight Cancer Institute | Phase 2 |
Generic filers with tentative approvals for CARFILZOMIB
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 60MG/VIAL | POWDER;INTRAVENOUS |
See Plans and Pricing | See Plans and Pricing | 10MG/VIAL | POWDER;INTRAVENOUS |
See Plans and Pricing | See Plans and Pricing | 60MG/VIAL | POWDER;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
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 |