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Serving leading biopharmaceutical companies globally:

Baxter
Citi
Merck
Fish and Richardson
Cipla
Queensland Health
US Department of Justice
Moodys
Medtronic
Argus Health

Generated: October 20, 2017

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 three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. 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. Three suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.

Summary for NDA: 022117

Tradename:
1
Applicant:
1
Ingredient:
1
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

Summary 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:
Regulatory Exclusivity Expiration:Jan 13, 2020
Regulatory Exclusivity Use:MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
Regulatory Exclusivity Expiration:Mar 17, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION


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Serving leading biopharmaceutical companies globally:

Fuji
Novartis
Federal Trade Commission
Cipla
Argus Health
Teva
Covington
McKesson
Accenture
McKinsey

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.

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