ALECENSA Drug Patent Profile

When do Alecensa patents expire, and when can generic versions of Alecensa launch?

Alecensa is a drug marketed by Hoffmann-la Roche and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty patent family members in thirty-eight countries.

The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Alecensa

Alecensa was eligible for patent challenges on December 11, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 24, 2035. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ALECENSA

International Patents:	130
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	20
Patent Applications:	1,275
Drug Prices:	Drug price information for ALECENSA
What excipients (inactive ingredients) are in ALECENSA?	ALECENSA excipients list
DailyMed Link:	ALECENSA at DailyMed

See drug prices for ALECENSA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ALECENSA

NDA:

208434

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 ALECENSA

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 ALECENSA clinical trials

Pharmacology for ALECENSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALECENSA

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

Paragraph IV (Patent) Challenges for ALECENSA

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 ALECENSA

ALECENSA is protected by five US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ALECENSA

FDA Regulatory Exclusivity protecting ALECENSA

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			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes				Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes

International Patents for ALECENSA

When does loss-of-exclusivity occur for ALECENSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Malaysia

Mexico

Russian Federation

Singapore

South Africa

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALECENSA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3135287	PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Singapore	10202009484W	PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
China	103052386	Composition containing tetracyclic compound
Japan	2016104762	４環性化合物を高用量含有する製剤 (FORMULATION CONTAINING HIGH DOSE OF TETRACYCLIC COMPOUND)
Serbia	58855	TETRACIKLIČNA JEDINJENJA (TETRACYCLIC COMPOUND)
Brazil	PI1011649	compostos tetracíclicos e composição farmacêutica que os compreende

Supplementary Protection Certificates for ALECENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	C02441753/01	Switzerland		PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017
2441753	2017026	Norway		PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	17C1019	France		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753	132017000079367	Italy		PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220
2441753	C20170023 00233	Estonia		PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017