DYANAVEL XR Drug Patent Profile
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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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR
Generic Entry Dates for DYANAVEL XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;ORAL |
Generic Entry Dates for DYANAVEL XR*:
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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tris Pharma, Inc. | Phase 4 |
Tris Pharma, Inc. | Phase 3 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DYANAVEL XR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations containing drug - ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Tris Pharma Inc | DYANAVEL XR 5 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-001 | Nov 4, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Tris Pharma Inc | DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-002 | Nov 4, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
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
Patent: 07227569
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 6867
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0709606
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 45855
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1400343
Estimated Expiration: ⤷ Try a Trial
Patent: 2488652
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 18160
Estimated Expiration: ⤷ Try a Trial
Patent: 28205
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 18160
Estimated Expiration: ⤷ Try a Trial
Patent: 28205
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4042
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 79086
Estimated Expiration: ⤷ Try a Trial
Patent: 09530298
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 35569
Estimated Expiration: ⤷ Try a Trial
Patent: 08140944
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1495146
Estimated Expiration: ⤷ Try a Trial
Patent: 080108520
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 78573
Estimated Expiration: ⤷ Try a Trial
Patent: 96039
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 0812649
Estimated Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | |
Taiwan | 200812649 | Modified release formulations containing drug-ion exchange resin complexes | ⤷ Try a Trial |
China | 102488652 | Modified release formulations containing drug-ion exchange resin complexes | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |