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Serving 500+ biopharmaceutical companies globally:

US Army
Dow
Baxter
McKinsey
Citi
Fuji
Medtronic
Daiichi Sankyo
UBS
Harvard Business School

Generated: June 25, 2017

DrugPatentWatch Database Preview

QUILLIVANT XR Drug Profile

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What is the patent landscape for Quillivant Xr, and when can generic versions of Quillivant Xr launch?

Quillivant Xr is a drug marketed by Nextwave Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fourteen countries.

The generic ingredient in QUILLIVANT XR is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: QUILLIVANT XR

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list31
Clinical Trials: see list2
Patent Applications: see list2,350
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:QUILLIVANT XR at DailyMed

Pharmacology for Tradename: QUILLIVANT XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes8,062,667► SubscribeY ► Subscribe
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes8,465,765► SubscribeY ► Subscribe
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes8,956,649► SubscribeY ► Subscribe
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes8,287,903► SubscribeY ► Subscribe
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes9,040,083► SubscribeY ► Subscribe
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Paragraph IV activity for: QUILLIVANT XR

Drugname Dosage Strength RLD Submissiondate
methylphenidate hydrochlorideExtended-release Oral Suspension5 mg/mLQuillivant XR8/2/2013

Non-Orange Book Patents for Tradename: QUILLIVANT 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
8,597,684Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,790,700Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,883,217Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,202,537Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,747,902Modified 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: QUILLIVANT XR

Country Document Number Estimated Expiration
Spain2396039► Subscribe
South Korea101495146► Subscribe
Russian Federation2435569► Subscribe
Denmark2018160► Subscribe
China102488652► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Merck
Novartis
Express Scripts
Moodys
Fuji
US Army
Cantor Fitzgerald
Farmers Insurance
Daiichi Sankyo

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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