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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 210526


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NDA 210526 describes DYANAVEL XR 5, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DYANAVEL XR 5 profile page.

The generic ingredient in DYANAVEL XR 5 is amphetamine; amphetamine aspartate/dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine; amphetamine aspartate/dextroamphetamine sulfate profile page.
Summary for 210526
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210526
Generic Entry Date for 210526*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, 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: 210526
Suppliers and Packaging for NDA: 210526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYANAVEL XR 10 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526 NDA NextWave Pharmaceuticals, Inc 24478-106 24478-106-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)
DYANAVEL XR 15 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526 NDA NextWave Pharmaceuticals, Inc 24478-106 24478-106-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG;EQ 1MG BASE
Approval Date:Nov 4, 2021TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 24, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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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 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.