Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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 thirteen patent family members in thirty-one 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
Drug Prices for NUVIGIL

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Recent Clinical Trials for NUVIGIL

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

See all NUVIGIL clinical trials

Recent Litigation for NUVIGIL

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District Court Litigation
Case NameDate
Cephalon Inc. v. Unimark Remedies Ltd.2015-02-02
Cephalon Inc. v. Sandoz Inc.2011-09-06
Cephalon, Inc. v. Apotex Corp2010-12-14

See all NUVIGIL litigation

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
DB06413
FT-0672441
HY-15201
l-Modafinil
MFCD09841055
Nuvigil (TN)
S4645
SCHEMBL34489
UNII-R3UK8X3U3D component YFGHCGITMMYXAQ-LJQANCHMSA-N
UNII-V63XWA605I
V63XWA605I
W-5419
YFGHCGITMMYXAQ-LJQANCHMSA-N
ZB000629
ZINC6156
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
>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 021875-001 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Dow
Moodys
Boehringer Ingelheim
McKesson

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.