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Last Updated: October 12, 2024

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, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, 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 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
Kuwait UniversityEarly Phase 1
Genuine Research Center, EgyptPhase 1
Chemipharm Pharmaceutical Industries, EgyptPhase 1

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up100MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up200MGTablet; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for modafinil

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex MODAFINIL modafinil TABLET;ORAL 077667-001 Feb 3, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Natco Pharma MODAFINIL modafinil TABLET;ORAL 076594-002 Jul 16, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.