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Generated: September 21, 2017

DrugPatentWatch Database Preview

Armodafinil - Generic Drug Details

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

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 two 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. Thirteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: armodafinil

Tradenames:2
Patents:2
Applicants:5
NDAs:5
Drug Master File Entries: see list12
Suppliers / Packagers: see list13
Bulk Api Vendors: see list14
Clinical Trials: see list56
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
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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
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-002Mar 26, 2009DISCNYesNo► Subscribe► SubscribeY► Subscribe
Lupin Ltd
ARMODAFINIL
armodafinil
TABLET;ORAL200751-001Nov 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007ABRXYesNo► Subscribe► SubscribeY► Subscribe
Natco Pharma Ltd
ARMODAFINIL
armodafinil
TABLET;ORAL202768-002Nov 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
ARMODAFINIL
armodafinil
TABLET;ORAL200156-004Aug 29, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Natco Pharma Ltd
ARMODAFINIL
armodafinil
TABLET;ORAL202768-001Nov 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007ABRXYesNo► Subscribe► SubscribeY► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-004Jun 15, 2007ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Pharms Inc
ARMODAFINIL
armodafinil
TABLET;ORAL200043-002Jun 1, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009ABRXYesNo► Subscribe► 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;ORAL021875-004Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-002Mar 26, 2009► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-004Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-002Mar 26, 2009► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Fuji
US Department of Justice
Chubb
Covington
Harvard Business School
US Army
Argus Health
AstraZeneca
Boehringer Ingelheim

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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