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ADZENYS XR-ODT Drug Profile
When do Adzenys Xr-odt patents expire, and what generic alternatives are available?
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. 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 |
| 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 |
|---|---|
| Duke University | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
Recent Litigation for ADZENYS XR-ODT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Neos Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-12-13 |
Pharmacology for ADZENYS XR-ODT
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Synonyms for ADZENYS XR-ODT
| 24 HR Amphetamine aspartate |
| ADDERALL 10 |
| ADDERALL 12.5 |
| ADDERALL 15 |
| ADDERALL 20 |
| ADDERALL 30 |
| ADDERALL 5 |
| ADDERALL 7.5 |
| ADDERALL XR 10 |
| ADDERALL XR 15 |
| ADDERALL XR 20 |
| ADDERALL XR 25 |
| ADDERALL XR 30 |
| ADDERALL XR 5 |
| Amphetamine aspartate mixture with amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate |
| Dextroamphetamine sulfate mixture with dextroamphetamine saccharate and amphetamine aspartate monohydrate and amphetamine sulfate |
| S900000010 |
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 |
