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Last Updated: August 4, 2020

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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 freedom to operate?

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

Armodafinil has one hundred and fifteen patent family members in thirty-one countries.

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

Drug Prices for ARMODAFINIL

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Recent Clinical Trials for ARMODAFINIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of FloridaPhase 4
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all ARMODAFINIL clinical trials

Generic filers with tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial250MGTABLET;ORAL
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for ARMODAFINIL
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

US Patents and Regulatory Information for ARMODAFINIL

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;ORAL 021875-002 Mar 26, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-003 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ARMODAFINIL

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

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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 verification 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.