QUILLICHEW ER Drug Patent Profile

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When do Quillichew Er patents expire, and when can generic versions of Quillichew Er launch?

Quillichew Er is a drug marketed by Nextwave Pharms and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in fourteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quillichew Er

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

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Summary for QUILLICHEW ER

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	1
Patent Applications:	3,514
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUILLICHEW ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUILLICHEW ER
What excipients (inactive ingredients) are in QUILLICHEW ER?	QUILLICHEW ER excipients list
DailyMed Link:	QUILLICHEW ER at DailyMed

Drug patent expirations by year for QUILLICHEW ER

Recent Clinical Trials for QUILLICHEW ER

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

Sponsor	Phase
Pfizer	Phase 4

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Pharmacology for QUILLICHEW ER

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

Anatomical Therapeutic Chemical (ATC) Classes for QUILLICHEW ER

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

Paragraph IV (Patent) Challenges for QUILLICHEW ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUILLICHEW ER	Extended-release Chewable Tablets	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	207960	1	2016-04-25

US Patents and Regulatory Information for QUILLICHEW ER

QUILLICHEW ER is protected by ten US patents.

Patents protecting QUILLICHEW ER

Methylphenidate extended release chewable tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED

Methylphenidate extended release chewable tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Methylphenidate extended release chewable tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methylphenidate extended release chewable tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1

Methylphenidate extended release chewable tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED

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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 Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	⤷ 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 QUILLICHEW ER

See the table below for patents covering QUILLICHEW ER around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica	⤷ Try a Trial
Denmark	2428205		⤷ Try a Trial
European Patent Office	2675438	POUDRE ET SUSPENSION AQUEUSE AVEC LIBÉRATION PROLONGÉE COMPRENANT METHYLPHENIDATE (EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION COMPRISING METHYLPHENIDATE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration