Amphetamine; amphetamine aspartate/dextroamphetamine sulfate - Generic Drug Details
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What are the generic sources for amphetamine; amphetamine aspartate/dextroamphetamine sulfate and what is the scope of freedom to operate?
Amphetamine; amphetamine aspartate/dextroamphetamine sulfate
is the generic ingredient in five branded drugs marketed by Tris Pharma Inc and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amphetamine; amphetamine aspartate/dextroamphetamine sulfate has twenty-one patent family members in fourteen countries.
One supplier is listed for this compound.
Summary for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
| International Patents: | 21 |
| US Patents: | 10 |
| Tradenames: | 5 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | amphetamine; amphetamine aspartate/dextroamphetamine sulfate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
*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.
Pharmacology for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
| 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 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ⤷ 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 amphetamine; amphetamine aspartate/dextroamphetamine sulfate
| 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 | |
| >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.
ISSN: 2162-2639
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