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Last Updated: June 5, 2020

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Alectinib hydrochloride - Generic Drug Details

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What are the generic sources for alectinib hydrochloride and what is the scope of patent protection?

Alectinib hydrochloride is the generic ingredient in one branded drug marketed by Hoffmann-la Roche and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alectinib hydrochloride has one hundred and seven patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for alectinib hydrochloride
International Patents:107
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 32
Clinical Trials: 30
Patent Applications: 8
DailyMed Link:alectinib hydrochloride at DailyMed
Recent Clinical Trials for alectinib hydrochloride

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

SponsorPhase
Ulrik LassenPhase 2
GlaxoSmithKlinePhase 2
PfizerPhase 2

See all alectinib hydrochloride clinical trials

Pharmacology for alectinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
Synonyms for alectinib hydrochloride
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)
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 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-6,6-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]carbazole-3-carbonitrile,hydrochloride
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
AC-29721
ACN-050755
AF-802 hydrochloride
AK174941
Alecensa
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
BCP09075
C30H34N4O2.ClH
CH5424802 (Hydrochloride)
CH5424802 HCl
CH5424802 HCl salt, Alectinib HCl salt, AF802 HCl salt
CH5424802(Hydrochloride)
CHEBI:62268
CHEMBL3707320
CS-3480
D10450
DTXSID10154841
EX-A1553
GYABBVHSRIHYJR-UHFFFAOYSA-N
HY-13011A
KS-00001D3B
P9YY73LO6J
Q27104897
s5232
SB16516
SCHEMBL14991271
UNII-P9YY73LO6J
Paragraph IV (Patent) Challenges for ALECTINIB HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ALECENSA CAPSULE;ORAL alectinib hydrochloride 208434 2019-12-11

US Patents and Regulatory Information for alectinib hydrochloride

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 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
>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 alectinib hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2441753 132017000079367 Italy   Start Trial PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220
2441753 PA2017017 Lithuania   Start Trial PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753 17C1019 France   Start Trial PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753 300876 Netherlands   Start Trial PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Merck
McKinsey
AstraZeneca
Boehringer Ingelheim

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.