➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Mallinckrodt
Harvard Business School
Medtronic
Merck

Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022117


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 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. Two 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: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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Johnson and Johnson
Baxter
Medtronic
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.