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ADZENYS XR-ODT Drug Profile
» See Plans and Pricing
When do Adzenys Xr-odt patents expire, and when can generic versions of Adzenys Xr-odt launch?
Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. There are four patents protecting this drug.
This drug has two patent family members in two countries.
The generic ingredient in ADZENYS XR-ODT 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 Adzenys Xr-odt
There has been one patent litigation case 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 ADZENYS XR-ODT
| International Patents: | 2 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADZENYS XR-ODT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADZENYS XR-ODT |
| DailyMed Link: | ADZENYS XR-ODT at DailyMed |
Recent Clinical Trials for ADZENYS XR-ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
| Duke University | Phase 2 |
Pharmacology for ADZENYS XR-ODT
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for ADZENYS XR-ODT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | amphetamine | 204326 | 2016-05-10 |
US Patents and Regulatory Information for ADZENYS XR-ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-001 | Jan 27, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-006 | Jan 27, 2016 | 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 ADZENYS XR-ODT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013003622 | Start Trial |
| European Patent Office | 2726066 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
