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Last Updated: April 9, 2020

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ALECENSA Drug Profile


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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

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Summary for ALECENSA
Drug patent expirations by year for ALECENSA
Drug Prices for ALECENSA

See drug prices for ALECENSA

Generic Entry Opportunity Date for ALECENSA
Generic Entry Date for ALECENSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Roche Pharma AGPhase 2
Instituto Nacional de Cancerologia de MexicoPhase 2
National Cancer Institute (NCI)Phase 2

See all ALECENSA clinical trials

Pharmacology for ALECENSA
Drug ClassKinase Inhibitor
Mechanism of ActionKinase 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

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

Supplementary Protection Certificates for ALECENSA

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
McKesson
AstraZeneca
Mallinckrodt
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.