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Last Updated: February 2, 2023

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 two suppliers. 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. Seven 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
Formulation / Manufacturing:see details
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:RXDosage:TABLET;SUBLINGUALStrengthEQ 5MG BASE
Approval Date:Aug 13, 2009TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 6, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Oct 6, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 10MG BASE
Approval Date:Aug 13, 2009TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 6, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022117

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

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