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Boehringer Ingelheim
Argus Health
QuintilesIMS
AstraZeneca
US Department of Justice
Fish and Richardson
Cerilliant
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Generated: October 21, 2018

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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.

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

Drug patent expirations by year for NUVIGIL
Synonyms for NUVIGIL
(-) modafinil
(-)-(R)-modafinil
(-)-2-((R)-(Diphenylmethyl)sulfinyl)acetamide
(-)-2-[(r)-(diphenylmethyl)sulfinyl]acetamide
(-)-2R-[(Diphenylmethyl)sulfinyl]acetamide
(-)-Modafinil
(R)-(-)-Modafinil
(R)-2-(benzhydrylsulfinyl)acetamide
(R)-Modafinil
(R)-Modafinil; 2-[(R)-(Diphenylmethyl)sulfinyl]-acetamide, CEP 10952, CRL 40982, Nuvigil
112111-43-0
2-[(R)-(Diphenylmethyl)sulfinyl]acetamide
ACE037
Acetamide, 2-[(R)-(diphenylmethyl)sulfinyl]-
AJ-08267
AKOS030211019
API0000100
Armodafinil
Armodafinil (USAN/INN)
Armodafinil [USAN:INN]
Armodafinil, >=98% (HPLC)
armodafinilo
armodafinilum
BDBM50336892
CCG-230228
CEP 10953
CEP-10952
CEP-10953
CHEBI:77590
CHEMBL1201192
CRL 40982
CRL-40982
CS-0665
D03215
D0J5RN
DB06413
FT-0672441
HY-15201
l-Modafinil
MFCD09841055
Nuvigil (TN)
R-modafinil
S4645
SCHEMBL34489
UNII-R3UK8X3U3D component YFGHCGITMMYXAQ-LJQANCHMSA-N
UNII-V63XWA605I
V63XWA605I
W-5419
YFGHCGITMMYXAQ-LJQANCHMSA-N
ZB000629
ZINC6156

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NUVIGIL

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

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Paragraph IV (Patent) Challenges for NUVIGIL
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 100 mg and 200 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 50 mg, 150 mg and 250 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
QuintilesIMS
AstraZeneca
US Department of Justice
Fish and Richardson
Cerilliant
Federal Trade Commission
Dow

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