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DYANAVEL XR Drug 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 one NDA. There are six patents protecting this drug.
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
US ANDA Litigation and 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: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,247 |
| 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 |
| DailyMed Link: | DYANAVEL XR at DailyMed |
Generic Entry Opportunity Date for DYANAVEL XR
Generic Entry Date for DYANAVEL XR*:
Constraining patent/regulatory exclusivity:
NDA:
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.
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
| 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 | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tris Pharma Inc | DYANAVEL XR | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tris Pharma Inc | DYANAVEL XR | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 102488652 | Start Trial |
| Canada | 2645855 | Start Trial |
| Israel | 194042 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
