DYANAVEL XR Drug Patent Profile

Which patents cover Dyanavel Xr, and when can generic versions of Dyanavel Xr launch?

Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in two NDAs. There are eight patents protecting this drug.

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

The generic ingredient in DYANAVEL XR is amphetamine; amphetamine aspartate/dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine; amphetamine aspartate/dextroamphetamine sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Dyanavel Xr

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.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DYANAVEL XR

International Patents:	21
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	2
Patent Applications:	6,428
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DYANAVEL XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYANAVEL XR
What excipients (inactive ingredients) are in DYANAVEL XR?	DYANAVEL XR excipients list
DailyMed Link:	DYANAVEL XR at DailyMed

See drug prices for DYANAVEL XR

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

NDA:

208147

Dosage:

SUSPENSION, EXTENDED RELEASE;ORAL

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

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

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

See all DYANAVEL XR clinical trials

Pharmacology for DYANAVEL XR

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

US Patents and Regulatory Information for DYANAVEL XR

DYANAVEL XR is protected by six US patents.

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

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	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes			Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No			Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No			Y

International Patents for DYANAVEL XR

When does loss-of-exclusivity occur for DYANAVEL XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Russian Federation

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2018160
Taiwan	200812649	Modified release formulations containing drug-ion exchange resin complexes
China	102488652	Modified release formulations containing drug-ion exchange resin complexes