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Armodafinil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for armodafinil?

Armodafinil 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 six tentative approvals for this compound.

Summary for Generic Name: armodafinil

Tradenames:2
Patents:3
Applicants:5
NDAs:5
Drug Master File Entries: see list12
Suppliers / Packagers: see list14
Bulk Api Vendors: see list14
Clinical Trials: see list16
Patent Applications: see list3,772
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. Form Dosage
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007RXYesNo7,132,570*PED► SubscribeY► Subscribe
Natco Pharma Ltd
ARMODAFINIL
armodafinil
TABLET;ORAL202768-003Nov 28, 2016RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
ARMODAFINIL
armodafinil
TABLET;ORAL200043-002Jun 1, 2012RXNoNo► Subscribe► Subscribe
Lupin Ltd
ARMODAFINIL
armodafinil
TABLET;ORAL200751-003Nov 28, 2016RXNoNo► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007RXYesNo7,297,346*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: armodafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 20074,927,855*PED► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007RE37516*PED► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 20094,927,855*PED► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-004Jun 15, 20074,927,855*PED► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-002Mar 26, 2009RE37516*PED► Subscribe
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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 verifification 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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