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Carfilzomib - Generic Drug Details
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 Dr Reddys and Onyx Therap, and is included in two 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 seventeen patent family members in forty countries.
There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for carfilzomib
| International Patents: | 217 |
| US Patents: | 11 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 180 |
| Patent Applications: | 371 |
| 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 |
|---|---|
| Christian Buske | Phase 3 |
| Janssen, LP | Phase 3 |
| ZKS Ulm (Zentrum für Klinische Studien Ulm) | Phase 3 |
Recent Litigation for carfilzomib
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA | 2019-05-23 |
| Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc. | 2019-01-11 |
| Onyx Therapeutics, Inc. v. CIPLA Limited | 2018-04-20 |
Generic filers with tentative approvals for CARFILZOMIB
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 60MG/VIAL | POWDER;INTRAVENOUS |
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 |
Synonyms for carfilzomib
| (2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide |
| (2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide |
| (Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide |
| (alphaS)-alpha-[[2-(4-Morpholinyl)acetyl]amino]benzenebutanoyl-L-leucyl-N-[(1S)-3-methyl-1-[[(2R)-2-methyl-2-oxiranyl]carbonyl]butyl]-L-phenylalaninamide |
| (S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide |
| (S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide |
| 72X6E3J5AR |
| 868540-17-4 |
| AB0008111 |
| AB01565867_02 |
| AC-27051 |
| AK546882 |
| AKOS025401910 |
| AOB87759 |
| AS-17059 |
| BDBM50277889 |
| BLMPQMFVWMYDKT-NZTKNTHTSA-N |
| C40H57N5O7 |
| Carfilzomib (JAN/USAN/INN) |
| Carfilzomib (PR-171) |
| Carfilzomib [USAN:INN] |
| carfilzomib-pr-171 |
| Carfilzomib; PR171 |
| Carfilzomib?PR-171?/Kyprolis |
| Carfilzomib(PR171) |
| CAS-868540-17-4 |
| CHEBI:65347 |
| CHEMBL451887 |
| CS-0984 |
| CS-W004540 |
| D08880 |
| DB08889 |
| DSSTox_CID_28616 |
| DSSTox_GSID_48690 |
| DSSTox_RID_82886 |
| DTXSID4048690 |
| EX-A2037 |
| FT-0696769 |
| GTPL7420 |
| HY-10455 |
| J-501773 |
| KS-00000SR1 |
| Kyprolis |
| Kyprolis (TN) |
| L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)- |
| MLS006011102 |
| N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide |
| NCGC00249613-01 |
| NCGC00249613-02 |
| NCGC00249613-03 |
| ONO-7057 |
| PR-171 |
| Q15366934 |
| QCR-96 |
| S-7798 |
| s2853 |
| SB16813 |
| SC-91032 |
| SCHEMBL85165 |
| SMR004660024 |
| SR-01000941582 |
| SR-01000941582-1 |
| SW218090-2 |
| Tox21_113079 |
| Tox21_113079_1 |
| UNII-72X6E3J5AR |
| Y0441 |
| ZINC49841054 |
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 | 202714-001 | 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 | Y | Start Trial | ||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 |
|---|---|---|
| China | 102256616 | Start Trial |
| South Korea | 101299821 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006045066 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for carfilzomib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781688 | PA2016010,C1781688 | Lithuania | Start Trial | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 1781688 | PA2016010 | Lithuania | Start Trial | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 1781688 | 16C0017 | France | Start Trial | PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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