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 12, 2019

DrugPatentWatch Database Preview

ARMODAFINIL Drug Profile

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When do Armodafinil patents expire, and what generic alternatives are available?

Armodafinil is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc. and is included in six NDAs.

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

Drug patent expirations by year for ARMODAFINIL
Drug Prices for ARMODAFINIL

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Recent Clinical Trials for ARMODAFINIL

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SponsorPhase
University of FloridaPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all ARMODAFINIL clinical trials

Recent Litigation for ARMODAFINIL

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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 ARMODAFINIL litigation

Synonyms for ARMODAFINIL
(-) 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 (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
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 ARMODAFINIL
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 ARMODAFINIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc ARMODAFINIL armodafinil TABLET;ORAL 201514-001 Mar 25, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-004 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-001 Mar 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-001 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-005 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-001 Nov 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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