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Last Updated: January 19, 2022

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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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two 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

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Summary for ALECENSA
International Patents:122
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 87
Clinical Trials: 18
Patent Applications: 1,013
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 Generic Entry Opportunity 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
Ulrik LassenPhase 2
PfizerPhase 2
GlaxoSmithKlinePhase 2

See all ALECENSA clinical trials

Pharmacology for ALECENSA
Drug ClassKinase Inhibitor
Mechanism of Action Kinase Inhibitors
Paragraph IV (Patent) Challenges for ALECENSA
Tradename Dosage Ingredient NDA Submissiondate
ALECENSA CAPSULE;ORAL alectinib hydrochloride 208434 2019-12-11

US Patents and Regulatory Information for ALECENSA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALECENSA is ⤷  Try it Free.

This potential generic entry date is based on patent ⤷  Try it Free.

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 it Free
Patent Expiration: ⤷  Try it Free

Tetracyclic compound
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Composition comprising tetracyclic compound
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Tetracyclic compound
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

FDA Regulatory Exclusivity protecting ALECENSA

TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Exclusivity Expiration: ⤷  Try it Free

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 it Free

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 it Free ⤷  Try it Free Y ⤷  Try it Free
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ALECENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2441753 PA2017017,C2441753 Lithuania ⤷  Try it Free PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753 122017000048 Germany ⤷  Try it Free PRODUCT NAME: ALECTINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753 CA 2017 00024 Denmark ⤷  Try it Free PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/16/1169/01 20170220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
McKesson
AstraZeneca
Mallinckrodt
Medtronic

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.