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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 sixty-five patent family members in thirty-six 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.

Summary for ALECENSA

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	95
Clinical Trials:	9
Patent Applications:	37
Drug Prices:	Drug price information for ALECENSA
DailyMed Link:	ALECENSA at DailyMed

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.

Pharmacology for ALECENSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Synonyms for ALECENSA

1256589-74-8

3341AH

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)

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-6,6-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-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride

ACN-050755

AF-802 hydrochloride

AGN-PC-09O9BF

AK174941

AKOS025404940

Alecensa (TN)

Alectinib Hydrochloride

Alectinib hydrochloride (JAN)

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

alectinib monohydrochloride

AOB87772

AS-17062

C30H34N4O2.ClH

CH 5424802, Alectinib HCl

CH5424802 (Hydrochloride)

CH5424802 HCl

CH5424802 HCl (AF 802 HCl, Alectinib HCl)

CH5424802 HCl salt, Alectinib HCl salt, AF802 HCl salt

CH5424802 Hydrochloride

CH5424802(Hydrochloride)

CHEBI:62268

CHEMBL3707320

CS-3480

D10450

DTXSID10154841

EX-A1553

GYABBVHSRIHYJR-UHFFFAOYSA-N

HY-13011A

KS-00001D3B

MFCD27987893

MolPort-039-137-749

P9YY73LO6J

SCHEMBL14991271

UNII-P9YY73LO6J

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

International Patents for ALECENSA

Country	Document Number	Estimated Expiration
Mexico	2011013306
Singapore	187614
Slovenia	2441753
Malaysia	160110

Supplementary Protection Certificates for ALECENSA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000048	Germany		PRODUCT NAME: ALECTINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2017 00024	Denmark		PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/16/1169/01 20170220
90024-2	Sweden		PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/16/1169/001 20170220
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