NUVIGIL Drug Patent Profile

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Which patents cover Nuvigil, and what generic alternatives are available?

Nuvigil is a drug marketed by Cephalon and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and sixteen patent family members in thirty-one countries.

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuvigil

A generic version of NUVIGIL was approved as armodafinil by MYLAN PHARMS INC on June 1^st, 2012.

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Summary for NUVIGIL

International Patents:	116
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	32
Patent Applications:	4,235
Drug Prices:	Drug price information for NUVIGIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUVIGIL
What excipients (inactive ingredients) are in NUVIGIL?	NUVIGIL excipients list
DailyMed Link:	NUVIGIL at DailyMed

Drug patent expirations by year for NUVIGIL

Recent Clinical Trials for NUVIGIL

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

Sponsor	Phase
University of Florida	Phase 1
Teva Pharmaceutical Industries, Ltd.	N/A
University of Pennsylvania	N/A

See all NUVIGIL clinical trials

Paragraph IV (Patent) Challenges for NUVIGIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVIGIL	Tablets	armodafinil	100 mg	021875	1	2009-09-08
NUVIGIL	Tablets	armodafinil	200 mg	021875	1	2009-09-03
NUVIGIL	Tablets	armodafinil	50 mg, 150 mg and 250 mg	021875	1	2009-07-24

US Patents and Regulatory Information for NUVIGIL

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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	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	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 NUVIGIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NUVIGIL

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

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Country	Patent Number	Title	Estimated Expiration
Norway	20051138		⤷ Sign Up
United Kingdom	9524328		⤷ Sign Up
Japan	H09511754		⤷ Sign Up
Malaysia	129376	NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL	⤷ Sign Up
Finland	121454		⤷ Sign Up
Australia	2003270563		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for NUVIGIL

Recent Clinical Trials for NUVIGIL

Paragraph IV (Patent) Challenges for NUVIGIL

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