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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.

Summary for carfilzomib

International Patents:	212
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	176
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
Amgen	Phase 4
City of Hope Medical Center	Phase 1
University of Utah	Phase 1

See all carfilzomib clinical trials

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

See all carfilzomib litigation

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		60MG/VIAL	POWDER;INTRAVENOUS
		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

(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
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
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

International Patents for carfilzomib

Country	Patent Number	Estimated Expiration
Israel	217210
Cyprus	1114025
Portugal	2030981
South Korea	20070086924
Russian Federation	2006143664

Supplementary Protection Certificates for carfilzomib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	C 2016 014	Romania		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		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	PA2016010,C1781688	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119