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Last Updated: July 12, 2020

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PROVIGIL Drug Profile


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When do Provigil patents expire, and what generic alternatives are available?

Provigil is a drug marketed by Cephalon and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the modafinil profile page.

US ANDA Litigation and Generic Entry Outlook for Provigil

A generic version of PROVIGIL was approved as modafinil by MYLAN PHARMS INC on July 16th, 2012.

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Drug patent expirations by year for PROVIGIL
Drug Prices for PROVIGIL

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Drug Sales Revenue Trends for PROVIGIL

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Recent Clinical Trials for PROVIGIL

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SponsorPhase
American Academy of Sleep MedicinePhase 2
Emory UniversityPhase 2
Stanford UniversityPhase 3

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Paragraph IV (Patent) Challenges for PROVIGIL
Tradename Dosage Ingredient NDA Submissiondate
PROVIGIL TABLET;ORAL modafinil 020717

US Patents and Regulatory Information for PROVIGIL

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
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 AB RX Yes Yes   Start Trial   Start Trial Y   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 PROVIGIL

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 020717-001 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
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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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Dow
Johnson and Johnson
Baxter
Express Scripts

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