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Last Updated: May 24, 2022

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, Orbion Pharms, 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.

Drug Prices for modafinil

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Drug Sales Revenue Trends for modafinil

See drug sales revenues for modafinil

Recent Clinical Trials for modafinil

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

SponsorPhase
Bruyere Research InstitutePhase 3
Ottawa Hospital Research InstitutePhase 3
The Ottawa HospitalPhase 3

See all modafinil clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Appco MODAFINIL modafinil TABLET;ORAL 207196-002 Aug 16, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Pharms MODAFINIL modafinil TABLET;ORAL 090543-001 Sep 26, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Pharms Inc MODAFINIL modafinil TABLET;ORAL 076594-002 Jul 16, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-001 Nov 1, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aurobindo Pharma Ltd MODAFINIL modafinil TABLET;ORAL 202566-001 Sep 27, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for modafinil

Country Patent Number Title Estimated Expiration
South Korea 100911779 See Plans and Pricing
China 1681485 See Plans and Pricing
Germany 60219005 See Plans and Pricing
Mexico PA05002832 FORMULACIONES FARMACEUTICAS NUEVAS DE MODAFINIL. (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL.) See Plans and Pricing
Taiwan I316406 See Plans and Pricing
Japan 2004532863 See Plans and Pricing
Japan 5415662 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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