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: December 15, 2019

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Armodafinil - Generic Drug Details

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What are the generic sources for armodafinil and what is the scope of freedom to operate?

Armodafinil is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, Watson Labs Inc, and Cephalon, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Armodafinil has one hundred and fourteen patent family members in thirty-one countries.

There are twelve drug master file entries for armodafinil. Thirteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for armodafinil

See drug prices for armodafinil

Recent Clinical Trials for armodafinil

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

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

Identify potential future generic entrants

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

Generic filers with tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGTABLET;ORAL
  Start Trial  Start Trial50MGTABLET;ORAL
  Start Trial  Start Trial250MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-004 May 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-005 May 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-005 Nov 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-001 Nov 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc ARMODAFINIL armodafinil TABLET;ORAL 201514-001 Mar 25, 2019 DISCN 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

Expired US Patents for armodafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 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 021875-003 Jun 15, 2007   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009   Start Trial   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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