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-eight 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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Questions you can ask:
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Summary for ALECENSA
International Patents: | 138 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 22 |
Patent Applications: | 88 |
Drug Prices: | Drug price information for ALECENSA |
What excipients (inactive ingredients) are in ALECENSA? | ALECENSA excipients list |
DailyMed Link: | ALECENSA at DailyMed |


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
Sponsor | Phase |
---|---|
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Phase 2/Phase 3 |
University of Birmingham | Phase 2/Phase 3 |
Cancer Research UK | Phase 2/Phase 3 |
Pharmacology for ALECENSA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase 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 two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALECENSA is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for 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.
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 for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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: ⤷ Try for Free
Australia
Patent: 15250574
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷ Try for Free
Patent: 20230293
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2016021206
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 46518
Patent: PREPARATION CONTENANT UN COMPOSE TETRACYCLIQUE A HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷ Try for Free
Patent: 40565
Patent: PREPARATION CONTENANT UN COMPOSE TETRACYCLIQUE A HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
European Patent Office
Patent: 35287
Patent: PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷ Try for Free
Patent: 97659
Patent: PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À DOSE ÉLEVÉE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 2015163448
Patent: 4環性化合物を高用量含有する製剤
Estimated Expiration: ⤷ Try for Free
Patent: 59712
Estimated Expiration: ⤷ Try for Free
Patent: 29942
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Malaysia
Patent: 9913
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 16013809
Patent: FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.)
Estimated Expiration: ⤷ Try for Free
Patent: 21012300
Patent: FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.)
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 4713
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷ Try for Free
Patent: 3604
Patent: Preparation containing tetracyclic compound at high dose
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 24056
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ (OBTAINING A TETRACYCLIC COMPOUND CONTAINED IN A HIGH DOSE)
Estimated Expiration: ⤷ Try for Free
Patent: 16145057
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ
Estimated Expiration: ⤷ Try for Free
Patent: 20119391
Patent: ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 202009484W
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷ Try for Free
Patent: 201607623X
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1606447
Patent: PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2412321
Estimated Expiration: ⤷ Try for Free
Patent: 2478887
Estimated Expiration: ⤷ Try for Free
Patent: 160146800
Patent: 4환성 화합물을 고용량 함유하는 제제 (4 Preparation containing tetracyclic compound at high dose)
Estimated Expiration: ⤷ Try for Free
Patent: 220087583
Patent: 4환성 화합물을 고용량 함유하는 제제 (4 Preparation containing tetracyclic compound at high dose)
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 20943
Estimated Expiration: ⤷ Try for Free
Patent: 71839
Estimated Expiration: ⤷ Try for Free
Patent: 31128
Estimated Expiration: ⤷ Try for Free
Patent: 1622706
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷ Try for Free
Patent: 2114693
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷ Try for Free
Patent: 2235088
Patent: Formulation comprising tetracyclic compounds in high dose
Estimated Expiration: ⤷ Try for 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.
See the table below for additional patents covering ALECENSA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I531367 | ⤷ Try for Free | |
Norway | 2975024 | ⤷ Try for Free | |
New Zealand | 597477 | Tetracyclic compounds | ⤷ Try for Free |
Mexico | 2021012300 | FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALECENSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2441753 | LUC00022 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1169/001 20170220 |
2441753 | PA2017017 | Lithuania | ⤷ Try for Free | PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216 |
2441753 | 300876 | Netherlands | ⤷ Try for Free | PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220 |
2441753 | SPC/GB17/036 | United Kingdom | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for Alecensa
More… ↓