DrugPatentWatch Database Preview

ALECENSA Drug Profile

Email this page to a colleague

When do Alecensa patents expire, 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 ninety 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

< Available with Subscription >

Start Trial

Summary for ALECENSA

International Patents:	90
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	110
Clinical Trials:	9
Patent Applications:	53
Drug Prices:	Drug price information for ALECENSA
DailyMed Link:	ALECENSA at DailyMed

Drug patent expirations by year for ALECENSA

Generic Entry Opportunity Date for ALECENSA

Generic Entry Date for ALECENSA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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
Roche Pharma AG	Phase 2
Instituto Nacional de Cancerologia de Mexico	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
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-morpholin-4-ylpiperidin-1-yl)-11-oxo-5H-benzo[B]carbazole-3-carbonitrile,hydrochloride
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
AF-802,RG-7853
AF802
AK170451
AK174941
AKOS025290737
Alecensa (TN)
Alectinib
Alectinib (CH5424802)
Alectinib (Hydrochloride)
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
BCP02589
BCP09075
BCP9000514
BDBM50362781
C30H34N4O2
C30H34N4O2.ClH
cc-247
CH 5424802
CH-5424802
CH-5424802/RG-7853
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
HMS3744I17
HY-13011
HY-13011A
J-005256
J-519506
KDGFLJKFZUIJMX-UHFFFAOYSA-N
KS-0000062Z
KS-00001D3B
LIJ4CT1Z3Y
MLS006010971
NCGC00346688-01
NCGC00346688-04
P9YY73LO6J
Q21099132
Q27104897
QCR-83
RO-5424802
RO5424802
S-7691
s2762
s5232
SB16515
SB16516
SC-94173
SCHEMBL14991271
SCHEMBL896753
SMR004702775
UNII-LIJ4CT1Z3Y
UNII-P9YY73LO6J
Y0295
ZINC000066166864
ZINC66166864

Paragraph IV (Patent) Challenges for ALECENSA

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALECENSA	CAPSULE;ORAL	alectinib hydrochloride	208434	2019-12-11

US Patents and Regulatory Information for ALECENSA

+ Get email alerts for changes to this table

Glossary

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

International Patents for ALECENSA

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
China	103052386	Start Trial
Malaysia	160110	Start Trial
New Zealand	597477	Start Trial
European Patent Office	2975024	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ALECENSA

Subscribe to access the full database, or Start Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	2017026	Norway	Start Trial	PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	CR 2017 00024	Denmark	Start Trial	PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF, HERUNDER I FORM AF HYDROCHLORID; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	1790024-2	Sweden	Start Trial	PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/16/1169/001 20170220
2441753	17C1019	France	Start Trial	PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description