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Last Updated: January 21, 2021

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ALECENSA Drug 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.

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

The generic ingredient in ALECENSA is alectinib hydrochloride. Additional details are available on the alectinib hydrochloride profile page.

US ANDA Litigation and 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.

Indicators of Generic Entry

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Summary for ALECENSA
International Patents:116
US Patents:4
Applicants:1
NDAs:1
Bulk Api Vendors: 112
Clinical Trials: 11
Drug Prices: Drug price information for ALECENSA
DailyMed Link:ALECENSA at DailyMed
Drug patent expirations by year for ALECENSA
Drug Prices for ALECENSA

See drug prices for ALECENSA

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
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
GlaxoSmithKlinePhase 2
PfizerPhase 2

See all ALECENSA clinical trials

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

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   Start Trial   Start Trial Y   Start Trial
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hoffmann-la Roche ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 31/2017 Austria   Start Trial PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753 17C1019 France   Start Trial PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753 300876 Netherlands   Start Trial 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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