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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, 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: | 187 |
Patent Applications: | 2,991 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for carfilzomib |
DailyMed Link: | carfilzomib at DailyMed |
Recent Clinical Trials for carfilzomib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sorlandet Hospital HF | Phase 2/Phase 3 |
Førde Central Hospital | Phase 2/Phase 3 |
The Hospital of Vestfold | Phase 2/Phase 3 |
Generic filers with tentative approvals for CARFILZOMIB
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 60MG/VIAL | POWDER;INTRAVENOUS |
Start Trial | Start Trial | UNKNOWN | UNKNOWN |
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 | 202714-002 | 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 | ||||
Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | 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 |
International Patents for carfilzomib
Country | Patent Number | Estimated Expiration |
---|---|---|
Poland | 1819353 | Start Trial |
Japan | 2012041346 | Start Trial |
Singapore | 185306 | Start Trial |
Slovenia | 1781688 | Start Trial |
European Patent Office | 2260835 | Start Trial |
European Patent Office | 1745064 | Start Trial |
European Patent Office | 2349313 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for carfilzomib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1781688 | C 2016 014 | Romania | Start Trial | 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 | 12/2016 | Austria | Start Trial | PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123 |
1781688 | CA 2016 00014 | Denmark | Start Trial | PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123 |
1781688 | 300805 | Netherlands | Start Trial | PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123 |
1781688 | PA2016010 | Lithuania | Start Trial | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
1781688 | 132016000047656 | Italy | Start Trial | PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123 |
1781688 | PA2016010,C1781688 | Lithuania | Start Trial | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |