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Last Updated: April 10, 2021

DrugPatentWatch Database Preview

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-two patent family members in twenty-eight countries.

There are twenty-six drug master file entries for modafinil. Twenty-two 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

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

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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
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Hikma Pharms MODAFINIL modafinil TABLET;ORAL 090543-001 Sep 26, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-001 Nov 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare MODAFINIL modafinil TABLET;ORAL 078963-002 Sep 26, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Appco MODAFINIL modafinil TABLET;ORAL 207196-001 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 020717-001 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 020717-002 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 020717-002 Dec 24, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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