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Last Updated: January 16, 2021

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Details for New Drug Application (NDA): 020717

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NDA 020717 describes PROVIGIL, which is a drug marketed by Cephalon and is included in one NDA. There is one patent protecting this drug. Additional details are available on the PROVIGIL profile page.

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Additional details are available on the modafinil profile page.

Summary for 020717

Tradename:	PROVIGIL
Applicant:	Cephalon
Ingredient:	modafinil
Patents:	1
Formulation / Manufacturing:	see details

Paragraph IV (Patent) Challenges for 020717

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROVIGIL	TABLET;ORAL	modafinil	020717

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 24, 1998	TE:	AB	RLD:	Yes
Patent:	Start Trial	Patent Expiration:	May 29, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 24, 1998	TE:	AB	RLD:	Yes
Patent:	Start Trial	Patent Expiration:	May 29, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020717

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	Start Trial	Start Trial
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	Start Trial	Start Trial
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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