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ADZENYS XR-ODT Drug Profile
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When do Adzenys Xr-odt patents expire, and what generic alternatives are available?
This drug has two patent family members in two countries.
The generic ingredient in ADZENYS XR-ODT is amphetamine. There are fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for ADZENYS XR-ODT
| International Patents: | 2 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADZENYS XR-ODT |
| DailyMed Link: | ADZENYS XR-ODT at DailyMed |
Pharmacology for ADZENYS XR-ODT
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for ADZENYS XR-ODT
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-006 | Jan 27, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-002 | Jan 27, 2016 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for ADZENYS XR-ODT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,839,619 | Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles | ➤ Try a Free Trial |
| 9,072,680 | Compositions comprising methylphenidate complexed with ion-exchange resin particles | ➤ Try a Free Trial |
| 9,089,496 | Compositions comprising methylphenidate complexed with ion-exchange resin particles | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ADZENYS XR-ODT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013003622 | ➤ Try a Free Trial |
| European Patent Office | 2726066 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
