Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021875

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NDA 021875 describes NUVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NUVIGIL profile page.

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
Summary for 021875
Tradename:NUVIGIL
Applicant:Cephalon
Ingredient:armodafinil
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUVIGIL armodafinil TABLET;ORAL 021875 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3090 0093-3090-56 30 TABLET in 1 BOTTLE (0093-3090-56)
NUVIGIL armodafinil TABLET;ORAL 021875 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3092 0093-3092-56 30 TABLET in 1 BOTTLE (0093-3092-56)
Paragraph IV (Patent) Challenges for 021875
Tradename Dosage Ingredient NDA Submissiondate
NUVIGIL TABLET;ORAL armodafinil 021875 2009-09-08
NUVIGIL TABLET;ORAL armodafinil 021875 2009-09-03
NUVIGIL TABLET;ORAL armodafinil 021875 2009-07-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 15, 2007TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 18, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 26, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 18, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021875

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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