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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
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 |
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 |
|---|---|
| Ulrik Lassen | Phase 2 |
| Pfizer | Phase 2 |
| GlaxoSmithKline | Phase 2 |
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 | 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 |
International Patents for ALECENSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | PA2017017 | ⤷ Try it Free |
| Hong Kong | 1165794 | ⤷ Try it Free |
| Russian Federation | 2020119391 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated 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 |
