KYPROLIS Drug Patent Profile
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When do Kyprolis patents expire, and what generic alternatives are available?
Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and twenty patent family members in forty-two countries.
The generic ingredient in KYPROLIS 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 Kyprolis
A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.
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Summary for KYPROLIS
| International Patents: | 220 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 95 |
| Patent Applications: | 2,635 |
| Drug Prices: | Drug price information for KYPROLIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYPROLIS |
| What excipients (inactive ingredients) are in KYPROLIS? | KYPROLIS excipients list |
| DailyMed Link: | KYPROLIS at DailyMed |
Recent Clinical Trials for KYPROLIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wuhan Union Hospital, China | Phase 2 |
| Dong-A University Hospital | Phase 2 |
| GlaxoSmithKline | Phase 2 |
Pharmacology for KYPROLIS
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Paragraph IV (Patent) Challenges for KYPROLIS
| 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 KYPROLIS
KYPROLIS is protected by twenty US patents.
Patents protecting KYPROLIS
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds for enzyme inhibition
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Compounds for enzyme inhibition
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Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
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Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Composition for enzyme inhibition
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Compounds for enzyme inhibition
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Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Compounds for enzyme inhibition
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Patent Expiration: ⤷ Sign Up
Alkylated cyclodextrin compositions and processes for preparing and using the same
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Patented Use: USE IN COMBINATION WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
| 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 | ⤷ Sign Up | |||
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | ⤷ 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 KYPROLIS
| 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 KYPROLIS
When does loss-of-exclusivity occur for KYPROLIS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 99109
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KYPROLIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 1819353 | ⤷ Sign Up | |
| Russian Federation | 2384585 | СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ ФЕРМЕНТОВ (ENZYME INHIBITING COMPOUNDS) | ⤷ Sign Up |
| Singapore | 10201701794U | COMPOUNDS FOR PROTEASOME ENZYME INHIBITION | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KYPROLIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781688 | 625 | Finland | ⤷ Sign Up | |
| 1781688 | C20160008 00189 | Estonia | ⤷ Sign Up | PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015 |
| 1781688 | 93015 | Luxembourg | ⤷ Sign Up | 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 |
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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.
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