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Last Updated: April 20, 2024

ALECTINIB HYDROCHLORIDE - Generic Drug Details

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What are the generic 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alectinib hydrochloride has one hundred and thirty-five patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for ALECTINIB HYDROCHLORIDE

International Patents:	135
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	59
Patent Applications:	69
What excipients (inactive ingredients) are in ALECTINIB HYDROCHLORIDE?	ALECTINIB HYDROCHLORIDE excipients list
DailyMed Link:	ALECTINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALECTINIB HYDROCHLORIDE

Generic Entry Date for ALECTINIB HYDROCHLORIDE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 ALECTINIB HYDROCHLORIDE

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

Sponsor	Phase
University of Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3

See all ALECTINIB HYDROCHLORIDE clinical trials

Pharmacology for ALECTINIB HYDROCHLORIDE

Drug Class	Kinase 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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a 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 ALECTINIB HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2016145057	ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ	⤷ Try a Trial
Costa Rica	20110492	COMPUESTOS TETRACÍCLICOS	⤷ Try a Trial
France	17C1019		⤷ Try a Trial
Croatia	P20180615		⤷ Try a Trial
South Africa	201300020	COMPOSITON COMPRISING TETRACYCLIC COMPOUND	⤷ Try a Trial
Singapore	187614	COMPOSITION CONTAINING TETRACYCLIC COMPOUND	⤷ Try a Trial
South Korea	102478887		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALECTINIB HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	132017000079367	Italy	⤷ Try a Trial	PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220
2441753	SPC/GB17/036	United Kingdom	⤷ Try a Trial	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	2017026	Norway	⤷ Try a Trial	PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	31/2017	Austria	⤷ Try a Trial	PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	CA 2017 00024	Denmark	⤷ Try a Trial	PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	122017000048	Germany	⤷ Try a Trial	PRODUCT NAME: ALECTINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	2017/026	Ireland	⤷ Try a Trial	PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/16/1169/001 20170216
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.