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Carfilzomib - Generic Drug Details
» See Plans and Pricing
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
| Sponsor | Phase |
|---|---|
| Karyopharm Therapeutics Inc | Phase 2 |
| Hackensack Meridian Health | Phase 2 |
| Førde Central Hospital | 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 | 202714-003 | 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 |
International Patents for carfilzomib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1151966 | Start Trial |
| Israel | 179151 | Start Trial |
| Japan | 6714664 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
