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NUVIGIL Drug Profile

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Nuvigil is a drug marketed by Cephalon and is included in one NDA. It is available from ten suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the armodafinil profile page.

Summary for Tradename: NUVIGIL

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list10
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007RXNo7,132,570*PED► subscribeY► subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009RXNo7,132,570*PED► subscribeY► subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-002Mar 26, 2009DISCNNo7,297,346*PED► subscribeY► subscribe
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Expired Patents for Tradename: NUVIGIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007RE37516*PED► subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-004Jun 15, 2007RE37516*PED► subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 20074,927,855*PED► subscribe
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Paragraph IV activity for: NUVIGIL

Drugname Dosage Strength RLD Submissiondate
armodafinilTablets100 mg and 200 mgNuvigil9/11/2009
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