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

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

One supplier is listed for this compound.

Summary for alectinib hydrochloride

International Patents:	137
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	62
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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,350,214 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
Hunan Province Tumor Hospital	Phase 1/Phase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Joshua Palmer	Phase 1/Phase 2

See all alectinib hydrochloride clinical trials

Pharmacology for alectinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for alectinib hydrochloride

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	10,350,214	⤷ Subscribe	Y			⤷ Subscribe
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	9,126,931	⤷ Subscribe		Y		⤷ Subscribe
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	9,365,514	⤷ Subscribe	Y			⤷ Subscribe
>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
Poland	3345903		⤷ Subscribe
France	17C1019		⤷ Subscribe
European Patent Office	3345903	COMPOSÉS TÉTRACYCLIQUES (TETRACYCLIC COMPOUNDS)	⤷ Subscribe
European Patent Office	2975024	COMPOSÉS TÉTRACYCLIQUES (TETRACYCLIC COMPOUNDS)	⤷ Subscribe
China	113975243	以高用量含有四环性化合物的制剂 (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)	⤷ Subscribe
>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	PA2017017,C2441753	Lithuania	⤷ Subscribe	PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	132017000079367	Italy	⤷ Subscribe	PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220
2441753	2017026	Norway	⤷ Subscribe	PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	C20170023 00233	Estonia	⤷ Subscribe	PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017
2441753	300876	Netherlands	⤷ Subscribe	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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