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Last Updated: October 24, 2020

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ARMODAFINIL Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Armodafinil

A generic version of ARMODAFINIL was approved as armodafinil by MYLAN PHARMS INC on June 1st, 2012.

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Drug patent expirations by year 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

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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
Apotex Inc ARMODAFINIL armodafinil TABLET;ORAL 201514-001 Mar 25, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-004 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-001 Mar 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-001 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-005 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-001 Nov 28, 2016 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

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Boehringer Ingelheim
Moodys
Johnson and Johnson
Colorcon

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