MODAFINIL - Generic Drug Details

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What are the generic 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, Natco Pharma, 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 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:	20
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	165
Patent Applications:	6,890
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
⤷ Sign Up	⤷ Sign Up	200MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for MODAFINIL

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Watson Labs Inc	MODAFINIL	modafinil	TABLET;ORAL	076715-002	Nov 1, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	MODAFINIL	modafinil	TABLET;ORAL	076715-001	Nov 1, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	MODAFINIL	modafinil	TABLET;ORAL	202700-002	Oct 18, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Appco	MODAFINIL	modafinil	TABLET;ORAL	207196-002	Aug 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-001	Feb 3, 2014	AB	RX	No	No	⤷ 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 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	⤷ 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 MODAFINIL

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1109465		⤷ Sign Up
China	101606915		⤷ Sign Up
Iceland	2707		⤷ Sign Up
Germany	60328119		⤷ Sign Up
Eurasian Patent Organization	008506	НОВЫЕ ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ МОДАФИНИЛА (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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