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ALECENSA Drug Profile

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Which patents cover Alecensa, and when can generic versions of Alecensa launch?

Alecensa is a drug marketed by Hoffmann-la Roche and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-five patent family members in thirty-eight countries.

The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Alecensa

Alecensa was eligible for patent challenges on December 11, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 4, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALECENSA

International Patents:	85
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	107
Clinical Trials:	9
Patent Applications:	53
Drug Prices:	Drug price information for ALECENSA
DailyMed Link:	ALECENSA at DailyMed

See drug prices for ALECENSA

Generic Entry Opportunity Date for ALECENSA

NDA:

208434

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALECENSA

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

Sponsor	Phase
Instituto Nacional de Cancerologia de Mexico	Phase 2
Roche Pharma AG	Phase 2
National Cancer Institute (NCI)	Phase 2

See all ALECENSA clinical trials

Pharmacology for ALECENSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Synonyms for ALECENSA

1256580-46-7

1256580-46-7 , C30H34N4O2 , CH 5424802 , CH-5424802

1256589-74-8

1416163-60-4

3341AH

4CA-0118

5H-Benzo[B]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-ipperidinyl]-11-oxo-, hydrochloride (1:1)

5H-Benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-

5H-Benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-, hydrochloride (1:1)

9-ethyl-6,11-dihydro-6,6-dimethyl-8-(4-(4-morpholinyl)-1-piperidinyl)-11-oxo-5h-benzo(b)carbazole-3-carbonitrile

9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-

9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrile

9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrile hydrochloride

9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrile hydrochloride (1:1)

9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrileCH5424802

9-Ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile

9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile monohydrochloride salt

9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5h-benzo[b]carbazol-3-carbonitril

9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5H-benzo[b]carbazole-3-carbonitrile

9-ethyl-6,6-dimethyl-8-(4-morpholinopiperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile

9-Ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrile

9-Ethyl-6,6-Dimethyl-8-[4-(Morpholin-4-Yl)piperidin-1-Yl]-11-Oxo-6,11-Dihydro-5h-Benzo[b]carbazole-3-Carbonitrile

9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride

A8393

AB0035866

ABP000797

AC-29020

AC-29721

ACN-050755

AF 802

AF 802|||CH 5424802

AF-802

AF-802 hydrochloride

AF802

AGN-PC-09O9BF

AK170451

AK174941

AKOS025290737

AKOS025404940

Alecensa (TN)

Alectinib

Alectinib (CH5424802)

Alectinib (USAN/INN)

Alectinib [USAN:INN]

Alectinib Hydrochloride

Alectinib hydrochloride (JAN)

Alectinib Hydrochloride;AF-802 Hydrochloride;CH-5424802 Hydrochloride;RG-7853 Hydrochloride;RO-5424802 Hydrochloride

alectinib monohydrochloride

AOB87311

AOB87772

AS-17008

AS-17062

BC638868

BCP02589

BCP09075

BCP9000514

BDBM50362781

C30H34N4O2

C30H34N4O2.ClH

cc-247

CH 5424802

CH-5424802

CH-5424802/RG-7853

CH-5428402 HCl

CH5424802

CH5424802 (Hydrochloride)

CH5424802 HCl

CH5424802 HCl salt, Alectinib HCl salt, AF802 HCl salt

CH5424802,CAS:1256580-46-7

CH5424802(Alectinib)

CH5424802(Hydrochloride)

CH5424802/CH-5424802

CHEBI:62268

CHEBI:90936

CHEMBL1738797

CHEMBL3707320

CS-0518

CS-3480

D10450

D10542

DB11363

DTXSID10154841

DTXSID50154840

EMH

EX-A1553

EX-A406

FT-0748626

GTPL7739

GYABBVHSRIHYJR-UHFFFAOYSA-N

HY-13011

HY-13011A

J-005256

J-519506

KB-76034

KDGFLJKFZUIJMX-UHFFFAOYSA-N

KS-0000062Z

KS-00001D3B

LIJ4CT1Z3Y

MLS006010971

MolPort-023-293-545

MolPort-039-137-749

NCGC00346688-01

NCGC00346688-04

P9YY73LO6J

QCR-83

RL01191

S-7691

s2762

SB16515

SB16516

SC-94173

SCHEMBL14991271

SCHEMBL896753

SMR004702775

UNII-LIJ4CT1Z3Y

UNII-P9YY73LO6J

Y0295

ZINC66166864

US Patents and Regulatory Information for ALECENSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes				Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes

International Patents for ALECENSA

Country	Patent Number	Estimated Expiration
Taiwan	201613858
European Patent Office	2606886
South Africa	201106938
Taiwan	I526441
Japan	5628603
Ukraine	107796

Supplementary Protection Certificates for ALECENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	CR 2017 00024	Denmark		PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF, HERUNDER I FORM AF HYDROCHLORID; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	2017026	Norway		PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753	C20170023 00233	Estonia		PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017
2441753	C02441753/01	Switzerland		PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017
2441753	31/2017	Austria		PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220