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Last Updated: November 21, 2024

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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*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all DYANAVEL XR 10 clinical trials

Pharmacology for DYANAVEL XR 10

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

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

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

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
>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.

Country Patent Number Title Estimated Expiration
China 101400343 Modified release formulations containing drug-ion exchange resin complexes ⤷  Sign Up
Australia 2007227569 Modified release formulations containing drug-ion exchange resin complexes ⤷  Sign Up
Spain 2378573 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.