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DYANAVEL XR 10 Drug Patent Profile

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When do Dyanavel Xr 10 patents expire, and what generic alternatives are available?

Dyanavel Xr 10 is a drug marketed by Tris Pharma Inc and is included in one NDA. There are four patents protecting this drug.

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

The generic ingredient in DYANAVEL XR 10 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 10

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 15, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DYANAVEL XR 10

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	DYANAVEL XR 10 at DailyMed

Drug patent expirations by year for DYANAVEL XR 10

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR 10

Generic Entry Date for DYANAVEL XR 10^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 210526 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.

Recent Clinical Trials for DYANAVEL XR 10

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

Sponsor	Phase
Tris Pharma, Inc.	Phase 4
Tris Pharma, Inc.	Phase 3

See all DYANAVEL XR 10 clinical trials

Pharmacology for DYANAVEL XR 10

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

US Patents and Regulatory Information for DYANAVEL XR 10

DYANAVEL XR 10 is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DYANAVEL XR 10 is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DYANAVEL XR 10

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER

Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 10

See the table below for patents covering DYANAVEL XR 10 around the world.

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Country	Patent Number	Title	Estimated Expiration
Spain	2378573		⤷ Sign Up
Austria	E536867		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007109104		⤷ Sign Up
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА	⤷ Sign Up
South Korea	20080108520	MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration