ADZENYS XR-ODT Drug Patent 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 five 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. One supplier is listed for this compound. Additional details are available on the amphetamine profile page.
DrugPatentWatch® Generic Entry Outlook for Adzenys Xr-odt
There have been two 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
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Questions you can ask:
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Summary for ADZENYS XR-ODT
International Patents: | 2 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 1 |
Patent Applications: | 6,388 |
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 |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ADZENYS XR-ODT | Extended-release Orally Disintegrating Tablets | amphetamine | 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg | 204326 | 1 | 2016-05-10 |
US Patents and Regulatory Information for ADZENYS XR-ODT
ADZENYS XR-ODT is protected by five US patents.
Patents protecting ADZENYS XR-ODT
Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
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Patent Expiration: ⤷ Sign Up
Compositions and methods of making rapidly dissolving ionically masked formulations
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Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
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Patent Expiration: ⤷ Sign Up
Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
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Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles
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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 | 204326-006 | Jan 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-006 | Jan 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-001 | Jan 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-004 | Jan 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-005 | Jan 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps | ADZENYS XR-ODT | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326-002 | Jan 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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
See the table below for patents covering ADZENYS XR-ODT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2726066 | FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2013003622 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |