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 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 |


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
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 |
Pharmacology for ALECENSA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ALECENSA
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.
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
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: ⤷ Sign Up
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
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: ⤷ Sign Up
Australia
Patent: 15250574
Estimated Expiration: ⤷ Sign Up
Patent: 20230293
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016021206
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 46518
Estimated Expiration: ⤷ Sign Up
Patent: 40565
Estimated Expiration: ⤷ Sign Up
China
Patent: 6456651
Estimated Expiration: ⤷ Sign Up
Patent: 3975243
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 35287
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8363
Estimated Expiration: ⤷ Sign Up
Patent: 3152
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2015163448
Estimated Expiration: ⤷ Sign Up
Patent: 59712
Estimated Expiration: ⤷ Sign Up
Patent: 29942
Estimated Expiration: ⤷ Sign Up
Patent: 16104762
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9913
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16013809
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 24056
Estimated Expiration: ⤷ Sign Up
Patent: 16145057
Estimated Expiration: ⤷ Sign Up
Patent: 20119391
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202009484W
Estimated Expiration: ⤷ Sign Up
Patent: 201607623X
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1606447
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2412321
Estimated Expiration: ⤷ Sign Up
Patent: 2478887
Estimated Expiration: ⤷ Sign Up
Patent: 160146800
Estimated Expiration: ⤷ Sign Up
Patent: 220087583
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 20943
Estimated Expiration: ⤷ Sign Up
Patent: 71839
Estimated Expiration: ⤷ Sign Up
Patent: 1622706
Estimated Expiration: ⤷ Sign Up
Patent: 2114693
Estimated Expiration: ⤷ Sign Up
Patent: 2235088
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 |
---|---|---|---|
European Patent Office | 3135287 | PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE) | ⤷ Sign Up |
Singapore | 10202009484W | PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE | ⤷ Sign Up |
China | 103052386 | Composition containing tetracyclic compound | ⤷ Sign Up |
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) | ⤷ Sign Up |
Serbia | 58855 | TETRACIKLIČNA JEDINJENJA (TETRACYCLIC COMPOUND) | ⤷ Sign Up |
Brazil | PI1011649 | compostos tetracíclicos e composição farmacêutica que os compreende | ⤷ 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 | C02441753/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017 |
2441753 | 2017026 | Norway | ⤷ Sign Up | PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307 |
2441753 | 17C1019 | France | ⤷ Sign Up | PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220 |
2441753 | 300876 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220 |
2441753 | 132017000079367 | Italy | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |