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Last Updated: August 8, 2020

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Armodafinil - Generic Drug Details

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What are the generic drug 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

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SponsorPhase
University of FloridaPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of 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
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-001 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-005 May 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-004 Nov 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-004 Dec 7, 2018 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
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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