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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Healthtrust
Teva
Harvard Business School
Express Scripts
Accenture
Daiichi Sankyo
Fish and Richardson

Generated: May 26, 2018

DrugPatentWatch Database Preview

NUVIGIL Drug Profile

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When do Nuvigil patents expire, 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 two Paragraph IV challenges.

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

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 021875-001 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
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 ➤ 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 Submissiondate
➤ Subscribe Tablets 50 mg, 150 mg and 250 mg ➤ Subscribe 2009-07-24
➤ Subscribe Tablets 100 mg and 200 mg ➤ Subscribe 2009-09-11

Non-Orange Book US Patents for NUVIGIL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,382,200 Process for the preparation of and crystalline forms of optical enantiomers of modafinil ➤ Sign Up
8,729,305 Process for the preparation of and crystalline forms of optical enantiomers of modafinil ➤ Sign Up
7,229,644 Pharmaceutical formulations of modafinil ➤ Sign Up
8,975,442 Process for the preparation of and crystalline forms of optical enantiomers of modafinil ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Chubb
Teva
Harvard Business School
Fish and Richardson
Julphar
Chinese Patent Office
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.