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Last Updated: February 22, 2024

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 Aurobindo Pharma Ltd, Corepharma, 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 sixteen patent family members in thirty-one countries.

There are twelve drug master file entries for armodafinil. Twelve 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
Jazz PharmaceuticalsPhase 4
Charles Andrew Czeisler, MD, PhDPhase 4
University of FloridaPhase 1

See all armodafinil clinical trials

Generic filers with tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial250MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
NUVIGIL Tablets armodafinil 100 mg 021875 1 2009-09-08
NUVIGIL Tablets armodafinil 200 mg 021875 1 2009-09-03
NUVIGIL Tablets armodafinil 50 mg, 150 mg and 250 mg 021875 1 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 021875-004 Jun 15, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-001 Mar 6, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-005 May 9, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007 ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for armodafinil

Country Patent Number Title Estimated Expiration
European Patent Office 2679576 Procédé de préparation de formes cristallines des énantiomeres optiques du modafinil et leur composition pharmaceutique (Preparation methods of forms of optical enantiomers of modafinil and pharmaceutical composition thereof) ⤷  Try a Trial
France 2849029 PROCEDE DE PREPARATION ET FORMES CRISTALLINES DES ENANTIOMERES OPTIQUES DU MODAFINIL. (Production of new or known crystalline forms of enantiomers of modafinil, useful e.g. for treating hypersomnia and stimulating cognition, by crystallization from solvents other than ethanol) ⤷  Try a Trial
Malaysia 142926 METHOD OF THE PRODUCTION OF CRYSTALLINE FORMS AND CRYSTALLINE FORMS OF OPTICAL ENANTIOMERS OF MODAFINIL ⤷  Try a Trial
Norway 328805 ⤷  Try a Trial
Japan 2004532863 ⤷  Try a Trial
Japan 4443119 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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