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Generated: May 27, 2017

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Armodafinil - Generic Drug Details

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What are the generic sources for armodafinil and what is the scope of armodafinil patent protection?

is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Lupin Ltd, Watson Labs Inc, Natco Pharma Ltd, and Cephalon, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for armodafinil. Fourteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: armodafinil

Drug Master File Entries: see list12
Suppliers / Packagers: see list14
Bulk Api Vendors: see list14
Clinical Trials: see list16
Patent Applications: see list3,914
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:armodafinil at DailyMed

Tentative approvals for ARMODAFINIL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe50MGTABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
TABLET;ORAL021875-005Mar 26, 2009ABRXYesNo7,297,346*PED► SubscribeY► Subscribe
TABLET;ORAL021875-002Mar 26, 2009DISCNYesNo7,297,346*PED► SubscribeY► Subscribe
Mylan Pharms Inc
TABLET;ORAL200043-003Jun 1, 2012ABRXNoNo► Subscribe► Subscribe
Watson Labs Inc
TABLET;ORAL200156-004Aug 29, 2012DISCNNoNo► Subscribe► Subscribe
TABLET;ORAL021875-005Mar 26, 2009ABRXYesNo7,132,570*PED► SubscribeY► Subscribe
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  • Anticipate P&T budget requirements
  • Formulary management
  • Identify first generic entrants

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Expired Orange Book Patents

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Paragraph IV Activity

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Patent Maintenance

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Non-Orange Book Patents

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International Patents

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Supplementary Protection Certificates

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