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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 carfilzomib patent protection?

Carfilzomib is the generic ingredient in one branded drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Carfilzomib has one hundred and eighty-eight patent family members in thirty-six countries.

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

Summary for carfilzomib

International Patents:	188
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	146
Patent Applications:	306
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carfilzomib
DailyMed Link:	carfilzomib at DailyMed

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

(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

(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

AKOS025401910

AN-217

AOB87759

AS-17059

BC251806

BDBM50277889

BLMPQMFVWMYDKT-NZTKNTHTSA-N

C40H57N5O7

Carfilzomib (JAN/USAN/INN)

Carfilzomib (PR-171)

Carfilzomib [USAN:INN]

Carfilzomib?PR-171?/Kyprolis

Carfilzomib(PR171)

CAS-868540-17-4

CHEBI:65347

CHEMBL451887

CS-0984

CS-W004540

D00UVA

D08880

DB08889

DSSTox_CID_28616

DSSTox_GSID_48690

DSSTox_RID_82886

DTXSID4048690

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)-

MFCD11040997

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

PR-171

PX-171-007

QCR-96

RL05381

S-7798

s2853

SC-91032

SCHEMBL85165

SMR004660024

SR-01000941582

SR-01000941582-1

Tox21_113079

Tox21_113079_1

UNII-72X6E3J5AR

Y0441

ZINC49841054

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			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	No
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y	Y

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Non-Orange Book US Patents for carfilzomib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,198,270	Compounds for proteasome enzyme inhibition
8,207,124	Compounds for enzyme inhibition
8,324,174	Compounds for enzyme inhibition
8,088,741	Compounds for enzyme inhibition

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International Patents for carfilzomib

Country	Document Number	Estimated Expiration
Denmark	2261236
New Zealand	603739
Morocco	32806
South Korea	20150004797
Australia	2016265980

Supplementary Protection Certificates for carfilzomib

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
16/013	Ireland		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
0160008 00189	Estonia		PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
0805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123