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Last Updated: February 22, 2024

QUILLIVANT XR Drug Patent Profile


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When do Quillivant Xr patents expire, and what generic alternatives are available?

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

This drug has thirty patent family members in fourteen countries.

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

Drug patent expirations by year for QUILLIVANT XR
Drug Prices for QUILLIVANT XR

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Recent Clinical Trials for QUILLIVANT XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, DavisPhase 1
Matthew O'BrienPhase 4
Matthew J O'Brien, PhD, BCBA-DPhase 4

See all QUILLIVANT XR clinical trials

Pharmacology for QUILLIVANT XR
Paragraph IV (Patent) Challenges for QUILLIVANT XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QUILLIVANT XR Extended-release Oral Suspension methylphenidate hydrochloride 5 mg/mL 202100 2013-08-02

US Patents and Regulatory Information for QUILLIVANT XR

QUILLIVANT XR is protected by seven US patents.

Patents protecting QUILLIVANT XR

Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE COMPOSITION OF CLAIM 1

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for QUILLIVANT XR

See the table below for patents covering QUILLIVANT XR around the world.

Country Patent Number Title Estimated Expiration
Australia 2017202955 Extended release powder and aqueous suspension comprising methylphenidate ⤷  Try a Trial
Israel 227734 אבקה בעלת שחרור מושהה ותרחיף מימי המכיל מתילפנידאט (Extended release powder and aqueous suspension comprising methylphenidate) ⤷  Try a Trial
Brazil PI0709606 formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica ⤷  Try a Trial
Russian Federation 2008140944 КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА ⤷  Try a Trial
Austria E536867 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007109104 ⤷  Try a Trial
European Patent Office 2018160 FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Baxter
Johnson and Johnson
Moodys
Mallinckrodt

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