CARFILZOMIB Drug Patent Profile
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Which patents cover Carfilzomib, and when can generic versions of Carfilzomib launch?
Carfilzomib is a drug marketed by Apotex, Breckenridge, and Dr Reddys. and is included in four NDAs.
The generic ingredient in CARFILZOMIB is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Carfilzomib
A generic version of CARFILZOMIB was approved as carfilzomib by DR REDDYS on September 9th, 2019.
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Questions you can ask:
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Summary for CARFILZOMIB
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 228 |
| Patent Applications: | 2,635 |
| 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 |
|---|---|
| AbbVie | Phase 3 |
| Pfizer | Phase 3 |
| Hoffmann-La Roche | Phase 1/Phase 2 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | CARFILZOMIB | carfilzomib | POWDER;INTRAVENOUS | 211185-001 | Mar 20, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | CARFILZOMIB | carfilzomib | POWDER;INTRAVENOUS | 209330-002 | Jun 11, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | CARFILZOMIB | carfilzomib | POWDER;INTRAVENOUS | 209425-001 | Mar 16, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | CARFILZOMIB | carfilzomib | POWDER;INTRAVENOUS | 209330-001 | Jun 11, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | CARFILZOMIB | carfilzomib | POWDER;INTRAVENOUS | 209422-001 | Sep 9, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
