PROVIGIL Drug Patent 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-two 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 suppliers are listed for this compound. Additional details are available on the modafinil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Provigil

A generic version of PROVIGIL was approved as modafinil by ORBION PHARMS on September 26^th, 2012.

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Summary for PROVIGIL

International Patents:	62
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	71
Patent Applications:	5,315
Drug Prices:	Drug price information for PROVIGIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROVIGIL
What excipients (inactive ingredients) are in PROVIGIL?	PROVIGIL excipients list
DailyMed Link:	PROVIGIL at DailyMed

Drug patent expirations by year for PROVIGIL

Recent Clinical Trials for PROVIGIL

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

Sponsor	Phase
Kuwait University	Early Phase 1
Bruyere Research Institute	Phase 3
Ottawa Hospital Research Institute	Phase 3

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Pharmacology for PROVIGIL

Drug Class	Sympathomimetic-like Agent
Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

US Patents and Regulatory Information for PROVIGIL

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Glossary

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

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

International Patents for PROVIGIL

See the table below for patents covering PROVIGIL around the world.

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Country	Patent Number	Title	Estimated Expiration
Mexico	9602176	MODAFINILO TENIENDO TAMAÑO DE PARTICULAS DEFINIDO. (MODAFINIL HAVING DEFINED PARTICLE SIZE.)	⤷ Sign Up
Australia	2003270563		⤷ Sign Up
Japan	S53121724	NOVEL ACETOAMIDE DERIVATIVES	⤷ Sign Up
European Patent Office	0966962	Modafinil ayant une granulométrie définie (Modafinil having defined particle size)	⤷ Sign Up
Netherlands	188692		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for PROVIGIL

Recent Clinical Trials for PROVIGIL

Pharmacology for PROVIGIL

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