Details for New Drug Application (NDA): 022117

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NDA 022117 describes SAPHRIS, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SAPHRIS profile page.

The generic ingredient in SAPHRIS is asenapine maleate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.

Summary for 022117

Tradename:	SAPHRIS
Applicant:	Allergan
Ingredient:	asenapine maleate
Patents:	2

Pharmacology for NDA: 022117

Suppliers and Packaging for NDA: 022117

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117	NDA	Allergan, Inc.	0456-2402	0456-2402-10	1 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK
SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117	NDA	Allergan, Inc.	0456-2402	0456-2402-60	6 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	EQ 5MG BASE
Approval Date:	Aug 13, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Oct 6, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Oct 6, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	EQ 10MG BASE
Approval Date:	Aug 13, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Oct 6, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022117

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	⤷ Start Trial	⤷ Start Trial
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	⤷ Start Trial	⤷ Start Trial
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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