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Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208147

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NDA 208147 describes DYANAVEL XR, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DYANAVEL XR profile page.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for 208147
Tradename:DYANAVEL XR
Applicant:Tris Pharma Inc
Ingredient:amphetamine
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208147
Generic Entry Date for 208147*:
Constraining patent/regulatory exclusivity:
Dosage::
SUSPENSION, EXTENDED RELEASE;ORAL

*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: 208147
Suppliers and Packaging for NDA: 208147
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYANAVEL XR amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 NDA Tris Pharma Inc 27808-102 N 27808-102-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 2.5MG BASE/ML
Approval Date:Oct 19, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 19, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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Mallinckrodt
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Colorcon
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