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Last Updated: May 17, 2022

NUVIGIL Drug Patent Profile


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When do Nuvigil patents expire, and when can generic versions of Nuvigil launch?

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. Ten 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 1st, 2012.

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Drug patent expirations by year for NUVIGIL
Drug Prices for NUVIGIL

See drug prices for NUVIGIL

Recent Clinical Trials for NUVIGIL

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

SponsorPhase
University of FloridaPhase 1
University of PennsylvaniaN/A
Teva Pharmaceutical Industries, Ltd.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

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Japan 4443119 See Plans and Pricing
Japan 4719471 See Plans and Pricing
Australia 2003270563 See Plans and Pricing
Austria 357228 See Plans and Pricing
Finland 121454 See Plans and Pricing
Poland 181523 See Plans and Pricing
European Patent Office 2679578 Procédé de préparation et une forme cristalline des énantiomères optiques du modafinil (Preparation method and crystalline form of optical enantiomers of modafinil) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Dow
Boehringer Ingelheim
Mallinckrodt
AstraZeneca

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