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DYANAVEL XR Drug Profile

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Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug.

This drug has nineteen patent family members in fourteen countries.

The generic ingredient in DYANAVEL XR 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: DYANAVEL XR

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

Pharmacology for Tradename: DYANAVEL XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tris Pharma Inc
DYANAVEL XR
amphetamine
SUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYes8,062,667► subscribeY ► subscribe
Tris Pharma Inc
DYANAVEL XR
amphetamine
SUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYes8,883,217► subscribeY ► subscribe
Tris Pharma Inc
DYANAVEL XR
amphetamine
SUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYes8,747,902► subscribeY ► subscribe
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Non-Orange Book Patents for Tradename: DYANAVEL XR

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
8,202,537Modified release formulations containing drug-ion exchange resin complexes► subscribe
9,198,864Modified release formulations containing drug-ion exchange resin complexes► subscribe
8,790,700Modified release formulations containing drug-ion exchange resin complexes► 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: DYANAVEL XR

Country Document Number Estimated Expiration
Spain2378573► subscribe
Russian Federation2435569► subscribe
Austria536867► 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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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. thinkBiotech performs no independent verifification 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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