Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
McKesson
Citi
Julphar
Mallinckrodt
Cerilliant
US Department of Justice
Cipla

Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022117

« Back to Dashboard

NDA 022117 describes SAPHRIS, which is a drug marketed by Forest Labs Llc 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:Forest Labs Llc
Ingredient:asenapine maleate
Patents:3
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 Organon Pharmaceuticals USA 0052-0118 0052-0118-06 6 CASE in 1 CARTON (0052-0118-06) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK
SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117 NDA Organon Pharmaceuticals USA 0052-0118 0052-0118-82 2 CASE in 1 CARTON (0052-0118-82) > 1 BLISTER PACK in 1 CASE > 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
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
Regulatory Exclusivity Expiration:Mar 12, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Argus Health
Citi
Federal Trade Commission
Mallinckrodt
Daiichi Sankyo
UBS
Boehringer Ingelheim
Chinese Patent Office

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 verifification 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.