DrugPatentWatch Database Preview
ALECENSA Drug Profile
» See Plans and Pricing
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
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 |
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 |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
| GlaxoSmithKline | Phase 2 |
| Pfizer | Phase 2 |
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 |
International Patents for ALECENSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112013003879 | Start Trial |
| Japan | WO2012023597 | Start Trial |
| Russian Federation | 2724056 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
