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Serving leading biopharmaceutical companies globally:

Covington
Johnson and Johnson
Moodys
Fuji
McKinsey
AstraZeneca
Healthtrust
Julphar
Merck
Accenture

Generated: December 12, 2017

DrugPatentWatch Database Preview

QUILLIVANT XR Drug Profile

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When do Quillivant Xr patents expire, 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-seven 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Nextwave PharmsQUILLIVANT XRmethylphenidate hydrochlorideFOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
8,883,217Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,675,704Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,202,537Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,198,864Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,522,191Modified release formulations containing drug--ion exchange resin complexes► Subscribe
8,790,700Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,597,684Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,549,989Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,747,902Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,675,703Modified 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
South Korea101495146► Subscribe
Israel227734► Subscribe
Australia2007227569► Subscribe
World Intellectual Property Organization (WIPO)2007109104► Subscribe
China102488652► Subscribe
Taiwan200812649► Subscribe
Canada2825991► Subscribe
European Patent Office2018160► Subscribe
Japan5479086► Subscribe
Denmark2428205► 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Cerilliant
Merck
Harvard Business School
Baxter
Dow
Boehringer Ingelheim
Chubb
Argus Health

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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