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Last Updated: July 15, 2024

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ALECENSA Drug Patent Profile


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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-six patent family members in thirty-nine 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

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Summary for ALECENSA
International Patents:136
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 22
Patent Applications: 38
Drug Prices: Drug price information for ALECENSA
What excipients (inactive ingredients) are in ALECENSA?ALECENSA excipients list
DailyMed Link:ALECENSA at DailyMed
Drug patent expirations by year for ALECENSA
Drug Prices for ALECENSA

See drug prices for ALECENSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALECENSA
Generic Entry Date for ALECENSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPhase 2/Phase 3
University of BirminghamPhase 2/Phase 3
Cancer Research UKPhase 2/Phase 3

See all ALECENSA clinical trials

Pharmacology for ALECENSA
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
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 one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALECENSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Preparation containing tetracyclic compound at high dose
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Preparation containing tetracyclic compound at high dose
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tetracyclic compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Composition comprising tetracyclic compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tetracyclic compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting ALECENSA

FOR TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE, METASTATIC NON-SMALL-CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST, EXCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Exclusivity Expiration: ⤷  Sign Up

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

Patent: 0187
Patent: COMPOSICIÓN FARMACÉUTICA QUE CONTIENE UN INHIBIDOR DE ALK (QUINASA DE LINFOMA ANAPLÁSICO)
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15250574
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷  Sign Up

Patent: 20230293
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2016021206
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 46518
Patent: PREPARATION CONTENANT UN COMPOSE TETRACYCLIQUE A HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷  Sign Up

Patent: 40565
Patent: PREPARATION CONTENANT UN COMPOSE TETRACYCLIQUE A HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 6456651
Patent: 以高用量含有四环性化合物的制剂 (Preparation containing tetracyclic compound at high dose)
Estimated Expiration: ⤷  Sign Up

Patent: 3975243
Patent: 以高用量含有四环性化合物的制剂 (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 35287
Patent: PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8363
Patent: תכשירים המכילים מינון גבוה של תרכובת טטראציקלית, שיטות להכנתם ושימושים בהם (High dose tetracyclic compound containing compositions methods of producing same and uses thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 3152
Patent: תכשירים המכילים מינון גבוה של תרכובת טטראציקלית, שיטות להכנתם ושימושים בהם (High dose tetracyclic compound containing compositions methods of producing same and uses thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2015163448
Patent: 4環性化合物を高用量含有する製剤
Estimated Expiration: ⤷  Sign Up

Patent: 59712
Estimated Expiration: ⤷  Sign Up

Patent: 29942
Estimated Expiration: ⤷  Sign Up

Patent: 16104762
Patent: 4環性化合物を高用量含有する製剤 (FORMULATION CONTAINING HIGH DOSE OF TETRACYCLIC COMPOUND)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 9913
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 16013809
Patent: FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.)
Estimated Expiration: ⤷  Sign Up

Patent: 21012300
Patent: FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4713
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷  Sign Up

Patent: 3604
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 24056
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ (OBTAINING A TETRACYCLIC COMPOUND CONTAINED IN A HIGH DOSE)
Estimated Expiration: ⤷  Sign Up

Patent: 16145057
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ
Estimated Expiration: ⤷  Sign Up

Patent: 20119391
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202009484W
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷  Sign Up

Patent: 201607623X
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1606447
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2412321
Estimated Expiration: ⤷  Sign Up

Patent: 2478887
Estimated Expiration: ⤷  Sign Up

Patent: 160146800
Patent: 4환성 화합물을 고용량 함유하는 제제 (4 Preparation containing tetracyclic compound at high dose)
Estimated Expiration: ⤷  Sign Up

Patent: 220087583
Patent: 4환성 화합물을 고용량 함유하는 제제 (4 Preparation containing tetracyclic compound at high dose)
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 20943
Estimated Expiration: ⤷  Sign Up

Patent: 71839
Estimated Expiration: ⤷  Sign Up

Patent: 31128
Estimated Expiration: ⤷  Sign Up

Patent: 1622706
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷  Sign Up

Patent: 2114693
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷  Sign Up

Patent: 2235088
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷  Sign Up

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
Taiwan 201213320 Composition comprising tetracyclic compounds ⤷  Sign Up
Russian Federation 2725140 ТЕТРАЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ (TETRACYCLIC COMPOUNDS) ⤷  Sign Up
South Korea 102412321 ⤷  Sign Up
Portugal 2441753 ⤷  Sign Up
Singapore 11201607623X PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALECENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2441753 CR 2017 00024 Denmark ⤷  Sign Up PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF, HERUNDER I FORM AF HYDROCHLORID; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753 2017026 Norway ⤷  Sign Up PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753 C20170023 00233 Estonia ⤷  Sign Up PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017
2441753 2017/026 Ireland ⤷  Sign Up PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/16/1169/001 20170216
2441753 SPC/GB17/036 United Kingdom ⤷  Sign Up 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
>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.