DrugPatentWatch Database Preview
SECUADO Drug Profile
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Which patents cover Secuado, and what generic alternatives are available?
Secuado is a drug marketed by Hisamitsu and is included in one NDA. There are three patents protecting this drug.
This drug has thirty-eight patent family members in nine countries.
The generic ingredient in SECUADO is asenapine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the asenapine profile page.
US ANDA Litigation and Generic Entry Outlook for Secuado
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 25, 2033. This may change due to patent challenges or generic licensing.
There are two tentative approvals for the generic drug (asenapine), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SECUADO
| International Patents: | 38 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| DailyMed Link: | SECUADO at DailyMed |
Generic Entry Opportunity Date for SECUADO
Generic Entry Date for SECUADO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SYSTEM;TRANSDERMAL |
*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.
Pharmacology for SECUADO
| Drug Class | Atypical Antipsychotic |
US Patents and Regulatory Information for SECUADO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hisamitsu | SECUADO | asenapine | SYSTEM;TRANSDERMAL | 212268-001 | Oct 11, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Hisamitsu | SECUADO | asenapine | SYSTEM;TRANSDERMAL | 212268-002 | Oct 11, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Hisamitsu | SECUADO | asenapine | SYSTEM;TRANSDERMAL | 212268-001 | Oct 11, 2019 | RX | Yes | No | Start Trial | Start Trial | 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 SECUADO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2878300 | Start Trial |
| European Patent Office | 2878299 | Start Trial |
| South Korea | 102013478 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SECUADO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0746317 | 10C0056 | France | Start Trial | PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901 |
| 0746317 | SPC/GB10/046 | United Kingdom | Start Trial | PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901 |
| 0746317 | C300461 | Netherlands | Start Trial | PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
