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Generated: October 21, 2018

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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 armodafinil freedom to operate?

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

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

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
D0J5RN
DB06413
FT-0672441
HY-15201
l-Modafinil
MFCD09841055
Nuvigil
Nuvigil (TN)
R-modafinil
S4645
SCHEMBL34489
UNII-R3UK8X3U3D component YFGHCGITMMYXAQ-LJQANCHMSA-N
UNII-V63XWA605I
V63XWA605I
W-5419
YFGHCGITMMYXAQ-LJQANCHMSA-N
ZB000629
ZINC6156
Tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up250MGTABLET;ORAL
➤ Sign Up➤ Sign Up200MGTABLET;ORAL
➤ Sign Up➤ Sign Up150MGTABLET;ORAL

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
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-002 Mar 6, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Watson Labs Inc ARMODAFINIL armodafinil TABLET;ORAL 200156-004 Aug 29, 2012 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-004 Nov 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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 ARMODAFINIL

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
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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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Merck
Healthtrust
Covington
Baxter
Cerilliant
Teva
Fuji
AstraZeneca

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