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Last Updated: July 3, 2020

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Modafinil - Generic Drug Details

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What are the generic drug sources for modafinil and what is the scope of freedom to operate?

Modafinil is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Apotex Inc, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Mylan Pharms Inc, Orchid Hlthcare, Watson Labs Inc, and Cephalon, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Modafinil has sixty-one patent family members in twenty-eight countries.

There are twenty-six drug master file entries for modafinil. Twenty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for modafinil

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Drug Sales Revenue Trends for modafinil

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Recent Clinical Trials for modafinil

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

SponsorPhase
United States Army Aeromedical Research LaboratoryPhase 2
American Academy of Sleep MedicinePhase 2
Emory UniversityPhase 2

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial100MGTABLET; ORAL
  Start Trial  Start Trial200MGTablet; 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 MODAFINIL
Tradename Dosage Ingredient NDA Submissiondate
PROVIGIL TABLET;ORAL modafinil 020717

US Patents and Regulatory Information for modafinil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd MODAFINIL modafinil TABLET;ORAL 202566-002 Sep 27, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-002 Nov 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd MODAFINIL modafinil TABLET;ORAL 202566-001 Sep 27, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd MODAFINIL modafinil TABLET;ORAL 202700-001 Oct 18, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc MODAFINIL modafinil TABLET;ORAL 077667-001 Feb 3, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Appco MODAFINIL modafinil TABLET;ORAL 207196-002 Aug 16, 2017 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 modafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998   Start Trial   Start Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998   Start Trial   Start Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998   Start Trial   Start Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998   Start Trial   Start Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998   Start Trial   Start Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
McKinsey
Medtronic
Merck
Moodys

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.