ADZENYS ER Drug Patent Profile
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Which patents cover Adzenys Er, and what generic alternatives are available?
Adzenys Er is a drug marketed by Neos Theraps Inc and is included in one NDA. There are three patents protecting this drug.
The generic ingredient in ADZENYS ER is amphetamine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Adzenys Er
A generic version of ADZENYS ER was approved as amphetamine by ACTAVIS LABS FL INC on June 22nd, 2023.
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Questions you can ask:
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Summary for ADZENYS ER
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for ADZENYS ER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADZENYS ER |
| What excipients (inactive ingredients) are in ADZENYS ER? | ADZENYS ER excipients list |
| DailyMed Link: | ADZENYS ER at DailyMed |
Recent Clinical Trials for ADZENYS ER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aytu BioPharma, Inc. | PHASE4 |
| Premier Research Group plc | PHASE4 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
US Patents and Regulatory Information for ADZENYS ER
ADZENYS ER is protected by three US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neos Theraps Inc | ADZENYS ER | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325-001 | Sep 15, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Neos Theraps Inc | ADZENYS ER | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325-001 | Sep 15, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Neos Theraps Inc | ADZENYS ER | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325-001 | Sep 15, 2017 | DISCN | Yes | No | ⤷ 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 ER
When does loss-of-exclusivity occur for ADZENYS ER?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
European Patent Office
Patent: 26066
Patent: FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ADZENYS ER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2726066 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2013003622 | ⤷ Start Trial | |
| 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) | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2013003622 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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