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Last Updated: August 11, 2022

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

Drug patent expirations by year for QUILLICHEW ER
Drug Prices for QUILLICHEW ER

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Recent Clinical Trials for QUILLICHEW ER

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SponsorPhase
PfizerPhase 4

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Pharmacology for QUILLICHEW ER
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 nine US patents.

Patents protecting QUILLICHEW ER

Methylphenidate extended release chewable tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methylphenidate extended release chewable tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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

Methylphenidate extended release chewable tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methylphenidate extended release chewable tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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 207960-001 Dec 4, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-003 Dec 4, 2015 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

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Merck
Boehringer Ingelheim
AstraZeneca
Mallinckrodt
Medtronic
McKesson

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