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