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ADZENYS XR-ODT Drug Profile

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Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. It is available from one supplier. 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-two 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 Tradename: ADZENYS XR-ODT

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: ADZENYS XR-ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Neos Theraps
ADZENYS XR-ODT
amphetamine
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL204326-001Jan 27, 2016RXNo9,265,737► subscribeY ► subscribe
Neos Theraps
ADZENYS XR-ODT
amphetamine
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL204326-005Jan 27, 2016RXNo8,840,924► subscribeY ► subscribe
Neos Theraps
ADZENYS XR-ODT
amphetamine
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL204326-006Jan 27, 2016RXYes9,265,737► subscribeY ► subscribe
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Non-Orange Book Patents for Tradename: 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
9,072,680Compositions comprising methylphenidate complexed with ion-exchange resin particles► subscribe
9,089,496Compositions comprising methylphenidate complexed with ion-exchange resin particles► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ADZENYS XR-ODT

Country Document Number Estimated Expiration
European Patent Office2726066► subscribe
World Intellectual Property Organization (WIPO)2013003622► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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