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Serving leading biopharmaceutical companies globally:

Colorcon
Deloitte
Cipla
Citi
Farmers Insurance
Chinese Patent Office
Julphar
Dow
Federal Trade Commission
Moodys

Generated: February 21, 2018

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.
Summary for QUILLIVANT XR
Drug patent expirations by year for QUILLIVANT XR
Pharmacology for QUILLIVANT XR

US Patents and Regulatory Information for 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;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nextwave Pharms QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 RX Yes Yes ➤ 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

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Paragraph IV (Patent) Challenges for QUILLIVANT XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Oral Suspension 5 mg/mL ➤ Subscribe 8/2/2013

Non-Orange Book US Patents for 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
8,202,537 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,597,684 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,522,191 Modified release formulations containing drug--ion exchange resin complexes ➤ Sign Up
8,747,902 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,883,217 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,549,989 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,198,864 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,790,700 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,337,890 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,675,704 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for QUILLIVANT XR

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Federal Trade Commission
UBS
Cantor Fitzgerald
McKinsey
Teva
US Department of Justice
Citi
Queensland 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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