ADZENYS ER Drug Patent Profile
✉ Email this page to a colleague
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.
This drug has two patent family members in two countries.
The generic ingredient in ADZENYS ER 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 Er
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ADZENYS ER?
- What are the global sales for ADZENYS ER?
- What is Average Wholesale Price for ADZENYS ER?
Summary for ADZENYS ER
International Patents: | 2 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 1 |
Patent Applications: | 4,378 |
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 |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
Duke University | Phase 2 |
US Patents and Regulatory Information for ADZENYS ER
ADZENYS ER is protected by three US patents.
Patents protecting ADZENYS ER
Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps Inc | ADZENYS ER | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325-001 | Sep 15, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Neos Theraps Inc | ADZENYS ER | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325-001 | Sep 15, 2017 | DISCN | 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 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: ⤷ Sign Up
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 | 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 |