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Last Updated: April 23, 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.

Summary for modafinil

International Patents:	62
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	164
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
Genuine Research Center, Egypt	Phase 1
Chemipharm Pharmaceutical Industries, Egypt	Phase 1

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	200MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	100MG	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
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cadila	MODAFINIL	modafinil	TABLET;ORAL	209966-002	Sep 14, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	MODAFINIL	modafinil	TABLET;ORAL	076594-002	Jul 16, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	MODAFINIL	modafinil	TABLET;ORAL	202566-002	Sep 27, 2012	AB	RX	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
>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	020717-001	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
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
>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
China	1511031		⤷ Try a Trial
Brazil	0314515		⤷ Try a Trial
Hong Kong	1061652		⤷ Try a Trial
Ukraine	88867	КОМПОЗИЦИЯ, КОТОРАЯ СОДЕРЖИТ МОДАФИНИЛ, И ЕЕ ПРИМЕНЕНИЕ;КОМПОЗИЦІЯ, ЩО МІСТИТЬ МОДАФІНІЛ, ТА ЇЇ ЗАСТОСУВАННЯ (FORMULATIONS COMPRISING MODAFINIL AND USE THEREOF)	⤷ Try a Trial
Canada	2498506	NOUVELLES FORMULATIONS PHARMACEUTIQUES DU 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.