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Last Updated: October 6, 2022

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 twenty-six patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for alectinib hydrochloride
International Patents:126
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 42
Clinical Trials: 54
Patent Applications: 69
What excipients (inactive ingredients) are in alectinib hydrochloride?alectinib hydrochloride excipients list
DailyMed Link:alectinib hydrochloride at DailyMed
Recent Clinical Trials for alectinib hydrochloride

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

SponsorPhase
Nuvalent Inc.Phase 1/Phase 2
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2

See all alectinib hydrochloride clinical trials

Pharmacology for alectinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of Action Kinase Inhibitors
Paragraph IV (Patent) Challenges for ALECTINIB HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ALECENSA Capsules alectinib hydrochloride 150 mg 208434 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 SPC/GB17/036 United Kingdom See Plans and Pricing PRODUCT NAME: ALECTINIB (9-ETHYL-6,6-DIMETHYL-8-(4-MORPHOLIN-4-YL-PIPERIDIN-1-YL)-11-OXO-6,11-DIHYDRO-5H-BENZO(B)CARBAZOLE-3-CARBONITRILE) OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/16/1169 (NI) 20170220; UK PLGB 00031/0843 20170220
2441753 C20170023 00233 Estonia See Plans and Pricing PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017
2441753 PA2017017,C2441753 Lithuania See Plans and Pricing PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753 CR 2017 00024 Denmark See Plans and Pricing PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF, HERUNDER I FORM AF HYDROCHLORID; REG. NO/DATE: EU/1/16/1169/01 20170220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Medtronic
McKinsey
Boehringer Ingelheim
Dow

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