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Last Updated: December 15, 2019

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Carfilzomib - Generic Drug Details

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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 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 twelve patent family members in forty countries.

There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for carfilzomib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenPhase 4
City of Hope Medical CenterPhase 1
University of UtahPhase 1

See all carfilzomib clinical trials

Recent Litigation for carfilzomib

Identify potential future generic entrants

District Court Litigation
Case NameDate
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA2019-05-23
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc.2019-01-11
Onyx Therapeutics, Inc. v. CIPLA Limited2018-04-20

See all carfilzomib litigation

Generic filers with tentative approvals for CARFILZOMIB
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG/VIAL POWDER;INTRAVENOUS
  Start Trial  Start Trial60MG/VIALPOWDER;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 ClassProteasome Inhibitor
Mechanism of ActionProteasome 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
(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]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-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide
(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
AN-217
AOB87759
AS-17059
BC251806
BDBM50277889
BLMPQMFVWMYDKT-NZTKNTHTSA-N
C40H57N5O7
Carfilzomib (JAN/USAN/INN)
Carfilzomib (PR-171)
Carfilzomib [USAN:INN]
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
KB-75946
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
MolPort-027-950-907
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
PX-171-007
QCR-96
RL05381
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 202714-003 Jun 7, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
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   Start Trial
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   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for carfilzomib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 C 2016 014 Romania   Start Trial PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1781688 CR 2016 00014 Denmark   Start Trial PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
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 122016000032 Germany   Start Trial PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Mallinckrodt
AstraZeneca
Johnson and Johnson
McKinsey

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