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Serving leading biopharmaceutical companies globally:

McKinsey
Teva
Chubb
Medtronic
McKesson
Citi
US Army
Dow
Colorcon
Johnson and Johnson

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207960

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NDA 207960 describes QUILLICHEW ER, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the QUILLICHEW ER profile page.

The generic ingredient in QUILLICHEW ER 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 NDA: 207960

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 207960

Suppliers and Packaging for NDA: 207960

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NDA NextWave Pharmaceuticals, Inc. 24478-120 24478-120-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-120-01)
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NDA NextWave Pharmaceuticals, Inc. 24478-130 24478-130-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-130-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE, CHEWABLE;ORALStrength20MG
Approval Date:Dec 4, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 4, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Feb 15, 2031Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Healthtrust
Cantor Fitzgerald
Queensland Health
QuintilesIMS
Daiichi Sankyo
Chubb
Mallinckrodt
Boehringer Ingelheim
McKinsey
Teva

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