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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022117

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NDA 022117 describes SAPHRIS, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from one supplier. There are three 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. One supplier is listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 022117
Tradename:SAPHRIS
Applicant:Forest Labs Llc
Ingredient:asenapine maleate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022117
Generic Entry Date for 022117*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;SUBLINGUAL

*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: 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
Paragraph IV (Patent) Challenges for 022117
Tradename Dosage Ingredient NDA Submissiondate
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 2017-07-27
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 2013-08-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 5MG BASE
Approval Date:Aug 13, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 13, 2020
Regulatory Exclusivity Use:BROADEN INITIAL STARTING DOSE FOR BIPOLAR I DISORDER TO 5-10MG TWICE DAILY
Regulatory Exclusivity Expiration:Jan 13, 2020
Regulatory Exclusivity Use:MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
Patent:  Start TrialPatent Expiration:Dec 9, 2020Product Flag?Substance Flag?Delist Request?Y

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