By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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ADZENYS XR-ODT Drug Profile
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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 and one Paragraph IV challenge.
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.
DrugPatentWatch® Generic Entry Outlook for Adzenys Xr-odt
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 9, 2026. This may change due to patent challenges or generic licensing.
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (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 |
| What excipients (inactive ingredients) are in ADZENYS XR-ODT? | ADZENYS XR-ODT excipients list |
| DailyMed Link: | ADZENYS XR-ODT at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADZENYS XR-ODT
Generic Entry Date for ADZENYS XR-ODT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, ORALLY DISINTEGRATING, 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 ADZENYS XR-ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 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 | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-006 | Jan 27, 2016 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-002 | Jan 27, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-001 | Jan 27, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-003 | Jan 27, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| >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 | Get Started Free |
| European Patent Office | 2726066 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
