Details for New Drug Application (NDA): 212268
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NDA 212268 describes SECUADO, which is a drug marketed by Hisamitsu and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the SECUADO profile page.
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.
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.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212268
Generic Entry Date for 212268*:
Constraining patent/regulatory exclusivity:
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 NDA: 212268
Suppliers and Packaging for NDA: 212268
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SECUADO | asenapine | SYSTEM;TRANSDERMAL | 212268 | NDA | Noven Therapeutics, LLC | 68968-0172 | 68968-0172-3 | 30 POUCH in 1 CARTON (68968-0172-3) / 1 d in 1 POUCH |
| SECUADO | asenapine | SYSTEM;TRANSDERMAL | 212268 | NDA | Noven Therapeutics, LLC | 68968-0172 | 68968-0172-7 | 7 POUCH in 1 CARTON (68968-0172-7) / 1 d in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 3.8MG/24HR | ||||
| Approval Date: | Oct 11, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,022,445 | Patent Expiration: | Jul 25, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,583,121 | Patent Expiration: | Jul 25, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH | ||||||||
| Patent: | 10,814,002 | Patent Expiration: | Jul 25, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH | ||||||||
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