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SAPHRIS Drug Profile

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Which patents cover Saphris, and what substitute generic drugs are available?

Saphris is a drug marketed by Forest Labs Llc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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 Tradename: SAPHRIS

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list23
Clinical Trials: see list9
Patent Applications: see list47
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SAPHRIS at DailyMed

Pharmacology for Tradename: SAPHRIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-003Mar 12, 2015RXYesNo7,741,358*PED► SubscribeY► Subscribe
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-002Aug 13, 2009RXYesYes► Subscribe► Subscribe
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-001Aug 13, 2009RXYesNo7,741,358*PED► SubscribeY► Subscribe
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-003Mar 12, 2015RXYesNo► Subscribe► Subscribe
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-002Aug 13, 2009RXYesYes► Subscribe► Subscribe
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Paragraph IV activity for: SAPHRIS

Drugname Dosage Strength RLD Submissiondate
asenapine maleateSublingual Tablets5 mg and 10 mgSaphris8/13/2013
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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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