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-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quillivant Xr

A generic version of QUILLIVANT XR was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

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Summary for QUILLIVANT XR

International Patents:	30
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	4
Patent Applications:	3,514
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUILLIVANT XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUILLIVANT XR
DailyMed Link:	QUILLIVANT XR at DailyMed

Drug patent expirations by year for QUILLIVANT XR

Recent Clinical Trials for QUILLIVANT XR

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

Sponsor	Phase
University of California, Davis	Phase 1
Matthew J O'Brien, PhD, BCBA-D	Phase 4
Matthew O'Brien	Phase 4

See all QUILLIVANT XR clinical trials

Pharmacology for QUILLIVANT XR

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for QUILLIVANT XR

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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: 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

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2675438	POUDRE ET SUSPENSION AQUEUSE AVEC LIBÉRATION PROLONGÉE COMPRENANT METHYLPHENIDATE (EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION COMPRISING METHYLPHENIDATE)	⤷ Try a Trial
Spain	2721900		⤷ Try a Trial
South Korea	20080108520	MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES	⤷ Try a Trial
Brazil	112013020537	suspensão aquosa e pó de liberação prolongada que compreendem metilfenidato	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration