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Last Updated: March 18, 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, 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. Nineteen 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
Chemipharm Pharmaceutical Industries, EgyptPhase 1
Genuine Research Center, EgyptPhase 1

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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.

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
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-001 Nov 1, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Pharms MODAFINIL modafinil TABLET;ORAL 090543-001 Sep 26, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc MODAFINIL modafinil TABLET;ORAL 076594-001 Jul 16, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex MODAFINIL modafinil TABLET;ORAL 077667-002 Feb 3, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orbion Pharms MODAFINIL modafinil TABLET;ORAL 078963-001 Sep 26, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc MODAFINIL modafinil TABLET;ORAL 076715-002 Nov 1, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 AB RX Yes Yes ⤷  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 modafinil

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

International Patents for modafinil

Country Patent Number Title Estimated Expiration
Norway 20035211 ⤷  Try a Trial
China 101606915 ⤷  Try a Trial
Malaysia 129376 NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL ⤷  Try a Trial
Cyprus 1109465 ⤷  Try a Trial
Brazil PI0210085 composição farmacêutica sólida contendo modafinila e processo para preparar uma composição farmacêutica sólida contendo modafinila ⤷  Try a Trial
Slovenia 1556026 ⤷  Try a Trial
Mexico PA05002832 FORMULACIONES FARMACEUTICAS NUEVAS DE MODAFINIL. (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.