DYANAVEL XR 5 Drug Patent Profile

Name: DYANAVEL XR 5 Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Dyanavel Xr 5 patents expire, and when can generic versions of Dyanavel Xr 5 launch?

Dyanavel Xr 5 is a drug marketed by Tris Pharma Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in fourteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Dyanavel Xr 5

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for DYANAVEL XR 5

International Patents:	21
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	DYANAVEL XR 5 at DailyMed

Drug patent expirations by year for DYANAVEL XR 5

Recent Clinical Trials for DYANAVEL XR 5

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rochester Center for Behavioral Medicine	PHASE4
Tris Pharma, Inc.	Phase 4
Tris Pharma, Inc.	Phase 3

See all DYANAVEL XR 5 clinical trials

Pharmacology for DYANAVEL XR 5

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for DYANAVEL XR 5

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYANAVEL XR 5	Extended-release Tablets	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	5 mg, 10 mg, 15 mg and 20 mg	210526	1	2025-01-22

US Patents and Regulatory Information for DYANAVEL XR 5

DYANAVEL XR 5 is protected by five US patents.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	11,590,081	⤷ Start Trial	Y			⤷ Start Trial
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	8,337,890	⤷ Start Trial	Y			⤷ Start Trial
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	12,458,592	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for DYANAVEL XR 5

See the table below for patents covering DYANAVEL XR 5 around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	E536867		⤷ Start Trial
Australia	2007227569	Modified release formulations containing drug-ion exchange resin complexes	⤷ Start Trial
Brazil	PI0709606	suspensão líquida administrável oralmente com características de liberação modificada	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration