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Last Updated: September 25, 2022

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

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Japan 5479086 See Plans and Pricing
South Korea 101495146 See Plans and Pricing
China 101400343 Modified release formulations containing drug-ion exchange resin complexes See Plans and Pricing
Denmark 2675438 See Plans and Pricing
Brazil PI0709606 formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Baxter
Johnson and Johnson
Moodys
Mallinckrodt

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 verification 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.