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Last Updated: January 17, 2021

DrugPatentWatch Database Preview

Alectinib hydrochloride - Generic Drug Details

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What are the generic drug sources for alectinib hydrochloride and what is the scope of freedom to operate?

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 sixteen patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for alectinib hydrochloride
International Patents:116
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 35
Clinical Trials: 36
Patent Applications: 10
DailyMed Link:alectinib hydrochloride at DailyMed
Recent Clinical Trials for alectinib hydrochloride

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

SponsorPhase
German Cancer Research CenterPhase 2
Fondazione per la Medicina PersonalizzataPhase 2
PfizerPhase 2

See all alectinib hydrochloride clinical trials

Pharmacology for alectinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
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   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 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   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 300876 Netherlands   Start Trial PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753 C02441753/01 Switzerland   Start Trial PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017
2441753 PA2017017,C2441753 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 LUC00022 Luxembourg   Start Trial PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1169/001 20170220
2441753 2017026 Norway   Start Trial PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
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Medtronic
McKinsey
Boehringer Ingelheim
Dow

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