DYANAVEL XR 5 Drug Patent Profile
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When do Dyanavel Xr 5 patents expire, and when can generic versions of Dyanavel Xr 5 launch?
Dyanavel Xr 5 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 5 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.
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Summary for DYANAVEL XR 5
| International Patents: | 21 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | DYANAVEL XR 5 at DailyMed |
Recent Clinical Trials for DYANAVEL XR 5
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tris Pharma, Inc. | Phase 4 |
| Tris Pharma, Inc. | Phase 3 |
Pharmacology for DYANAVEL XR 5
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for DYANAVEL XR 5
DYANAVEL XR 5 is protected by four US patents.
Patents protecting DYANAVEL XR 5
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 5 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-001 | Nov 4, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR 5 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-001 | Nov 4, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR 5 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-001 | Nov 4, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR 5 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-001 | 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 5
See the table below for patents covering DYANAVEL XR 5 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 | |
| Japan | 2009530298 | ⤷ Sign Up | |
| Russian Federation | 2008140944 | КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА | ⤷ Sign Up |
| Taiwan | 200812649 | Modified release formulations containing drug-ion exchange resin complexes | ⤷ 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.
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