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 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.
Anatomical Therapeutic Chemical (ATC) Classes for carfilzomib
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 |
---|---|---|---|
Chile | 2011000916 | Uso de una combinacion de un inhibidor de proteasoma epoxicetona peptidica o una sal farmaceutica aceptable del mismo, y uno o mas de otros agentes terapeuticos para tratar el cancer. | See Plans and Pricing |
Australia | 2005313975 | Composition for proteasome inhibition | See Plans and Pricing |
Japan | 2008509166 | See Plans and Pricing | |
European Patent Office | 3090737 | THÉRAPIE DE COMBINAISON AVEC PEPTIDES D'ÉPOXYCÉTONES (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES) | See Plans and Pricing |
Slovenia | 1781688 | See Plans and Pricing | |
Japan | 6081964 | See Plans and Pricing | |
Australia | 2005243140 | Synthesis of amino acid keto-epoxides | 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 | C 2016 014 | Romania | See Plans and Pricing | 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 | CR 2016 00014 | Denmark | See Plans and Pricing | PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. 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 | 362 5009-2016 | Slovakia | See Plans and Pricing | PRODUCT NAME: KARFILZOMIB; NAT. REGISTRATION NO/DATE: EU1/15/1060 20151123; FIRST REGISTRATION: EU EU/1/15/1060 20151123 |
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 | C01781688/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |