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Last Updated: August 8, 2020

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NUVIGIL Drug 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 two Paragraph IV challenges.

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

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

US ANDA 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

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Recent Clinical Trials for NUVIGIL

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
Alliance for Clinical Trials in OncologyPhase 3
Teva Pharmaceuticals USAPhase 4

See all NUVIGIL clinical trials

Paragraph IV (Patent) Challenges for NUVIGIL
Tradename Dosage Ingredient NDA Submissiondate
NUVIGIL TABLET;ORAL armodafinil 021875 2009-09-08
NUVIGIL TABLET;ORAL armodafinil 021875 2009-09-03
NUVIGIL TABLET;ORAL armodafinil 021875 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   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start 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 NUVIGIL

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

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