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, 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-one suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for modafinil

International Patents:	62
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	163
Patent Applications:	5,589
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for modafinil
Drug Sales Revenues:	Drug sales revenues for modafinil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for modafinil
What excipients (inactive ingredients) are in modafinil?	modafinil excipients list
DailyMed Link:	modafinil at DailyMed

See drug prices for modafinil

See drug sales revenues for modafinil

Recent Clinical Trials for modafinil

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

Sponsor	Phase
Kuwait University	Early Phase 1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	N/A
Shalvata Mental Health Center	Phase 2

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	100MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	200MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	200MG	Tablet; 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

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

US Patents and Regulatory Information for modafinil

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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
Appco	MODAFINIL	modafinil	TABLET;ORAL	207196-001	Aug 16, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	MODAFINIL	modafinil	TABLET;ORAL	077667-002	Feb 3, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Cadila	MODAFINIL	modafinil	TABLET;ORAL	209966-001	Sep 14, 2017	AB	RX	No	No	⤷ 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

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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	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Australia	2002318155		⤷ Try a Trial
Norway	20051138		⤷ Try a Trial
Hong Kong	1061652		⤷ Try a Trial
Slovenia	1556026		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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