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Last Updated: January 29, 2022

DrugPatentWatch Database Preview

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 five 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.
Summary for 212268
Tradename:SECUADO
Applicant:Hisamitsu
Ingredient:asenapine
Patents:5
DrugPatentWatch® Estimated Generic Entry Opportunity 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 68968-0173 68968-0173-3 30 POUCH in 1 CARTON (68968-0173-3) > 1 d in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYSTEM;TRANSDERMALStrength3.8MG/24HR
Approval Date:Oct 11, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 11, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Try it FreePatent Expiration:Jul 25, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Jul 25, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH

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Serving leading biopharmaceutical companies globally:

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