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Last Updated: March 28, 2024

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ALECENSA Drug Patent Profile


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When do Alecensa patents expire, and what generic alternatives are available?

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-five 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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  Try a Trial

Summary for ALECENSA
International Patents:135
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 21
Patent Applications: 46
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
University of ManchesterPhase 2/Phase 3
Hoffmann-La RochePhase 2/Phase 3
University of BirminghamPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Preparation containing tetracyclic compound at high dose
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tetracyclic compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Composition comprising tetracyclic compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tetracyclic compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  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
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
>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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 15250574
Estimated Expiration: ⤷  Try a Trial

Patent: 20230293
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016021206
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 46518
Estimated Expiration: ⤷  Try a Trial

Patent: 40565
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6456651
Estimated Expiration: ⤷  Try a Trial

Patent: 3975243
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 35287
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8363
Estimated Expiration: ⤷  Try a Trial

Patent: 3152
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2015163448
Estimated Expiration: ⤷  Try a Trial

Patent: 59712
Estimated Expiration: ⤷  Try a Trial

Patent: 29942
Estimated Expiration: ⤷  Try a Trial

Patent: 16104762
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9913
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16013809
Estimated Expiration: ⤷  Try a Trial

Patent: 21012300
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4713
Estimated Expiration: ⤷  Try a Trial

Patent: 3604
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 24056
Estimated Expiration: ⤷  Try a Trial

Patent: 16145057
Estimated Expiration: ⤷  Try a Trial

Patent: 20119391
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202009484W
Estimated Expiration: ⤷  Try a Trial

Patent: 201607623X
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1606447
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2412321
Estimated Expiration: ⤷  Try a Trial

Patent: 2478887
Estimated Expiration: ⤷  Try a Trial

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

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

Taiwan

Patent: 20943
Estimated Expiration: ⤷  Try a Trial

Patent: 71839
Estimated Expiration: ⤷  Try a Trial

Patent: 1622706
Estimated Expiration: ⤷  Try a Trial

Patent: 2114693
Estimated Expiration: ⤷  Try a Trial

Patent: 2235088
Estimated Expiration: ⤷  Try a Trial

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
Canada 2764653 COMPOSE TETRACYCLIQUE (TETRACYCLIC COMPOUNDS) ⤷  Try a Trial
Malaysia 189913 PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE ⤷  Try a Trial
Malaysia 160110 COMPOSITION COMPRISING TETRACYCLIC COMPOUND ⤷  Try a Trial
Taiwan 201213320 Composition comprising tetracyclic compounds ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALECENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2441753 1790024-2 Sweden ⤷  Try a Trial PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/16/1169/001 20170220
2441753 PA2017017 Lithuania ⤷  Try a Trial PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
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 CR 2017 00024 Denmark ⤷  Try a Trial 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

Make Better Decisions: Try a trial or see plans & pricing

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.