Details for New Drug Application (NDA): 208147
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NDA 208147 describes DYANAVEL XR, which is a drug marketed by Tris Pharma Inc and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the DYANAVEL XR profile page.
The generic ingredient in DYANAVEL XR 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.
The generic ingredient in DYANAVEL XR 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.
Summary for 208147
| Tradename: | DYANAVEL XR |
| Applicant: | Tris Pharma Inc |
| Ingredient: | amphetamine; amphetamine aspartate/dextroamphetamine sulfate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208147
Generic Entry Date for 208147*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, 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.
Pharmacology for NDA: 208147
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 208147
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | NDA | NextWave Pharmaceuticals, Inc | 24478-102 | 24478-102-01 | 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 2MG/ML;EQ 0.5MG BASE/ML | ||||
| Approval Date: | Oct 19, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,086,087 | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,590,228 | Patent Expiration: | Sep 7, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER | ||||||||
| Patent: | 8,062,667 | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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