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 Pharms Amgen, 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 patent family members in forty-two countries.
There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There are four tentative approvals for this compound.
Summary for CARFILZOMIB
International Patents: | 220 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 5 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 228 |
Patent Applications: | 6,016 |
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 |
---|---|
AbbVie | Phase 3 |
Pfizer | Phase 3 |
Hoffmann-La Roche | Phase 1/Phase 2 |
Generic filers with tentative approvals for CARFILZOMIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 60MG/VIAL | POWDER;INTRAVENOUS |
⤷ Sign Up | ⤷ Sign Up | 10MG/VIAL | POWDER;INTRAVENOUS |
⤷ Sign Up | ⤷ Sign Up | 60MG | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for CARFILZOMIB
Drug Class | Proteasome Inhibitor |
Mechanism of Action | Proteasome Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-003 | Jun 7, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 |
International Patents for CARFILZOMIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20130080064 | COMPOUNDS FOR PROTEASOME ENZYME INHIBITION | ⤷ Sign Up |
Luxembourg | 93015 | ⤷ Sign Up | |
Japan | 4743720 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CARFILZOMIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1781688 | CR 2016 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123 |
1781688 | 625 | Finland | ⤷ Sign Up | |
1781688 | SPC/GB16/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.