alecensa Drug Patent Profile
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Which patents cover Alecensa, 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
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 |
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 |
---|---|
University of Manchester | Phase 2/Phase 3 |
Hoffmann-La Roche | Phase 2/Phase 3 |
University of Birmingham | 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 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 | |||
>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 |
---|---|---|---|
Portugal | 3345903 | ⤷ Try a Trial | |
Canada | 2946518 | PREPARATION CONTENANT UN COMPOSE TETRACYCLIQUE A HAUTE DOSE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE) | ⤷ Try a Trial |
Taiwan | 201622706 | Formulation comprising tetracyclic compounds in high dose | ⤷ 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 | C20170023 00233 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017 |
2441753 | 300876 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220 |
2441753 | 132017000079367 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |