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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Cipla
Citi
UBS
Fuji
Julphar
Argus Health
Cerilliant
Harvard Business School

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202100

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NDA 202100 describes QUILLIVANT XR, which is a drug marketed by Nextwave Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUILLIVANT XR profile page.

The generic ingredient in QUILLIVANT XR is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 202100
Tradename:QUILLIVANT XR
Applicant:Nextwave Pharms
Ingredient:methylphenidate hydrochloride
Patents:7
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202100
Suppliers and Packaging for NDA: 202100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NDA NextWave Pharmaceuticals, Inc. 24478-190 N 24478-190-10
QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NDA NextWave Pharmaceuticals, Inc. 24478-200 N 24478-200-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;ORALStrength5MG/ML
Approval Date:Sep 27, 2012TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 15, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 15, 2031Product Flag?YSubstance Flag?Delist Request?
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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Argus Health
Cipla
Cantor Fitzgerald
US Army
Citi
Mallinckrodt
Healthtrust

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