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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
McKesson
Cipla
Teva
Boehringer Ingelheim
Federal Trade Commission
Queensland Health
Mallinckrodt
Argus Health

Generated: June 18, 2018

DrugPatentWatch Database Preview

ARMODAFINIL - Generic Drug Details

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What are the generic drug sources for armodafinil and what is the scope of armodafinil patent protection?

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.

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

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
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial250MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGTABLET;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
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-005 Nov 28, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-001 Mar 6, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ARMODAFINIL

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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Army
McKinsey
Express Scripts
Deloitte
AstraZeneca
Julphar
Baxter
Fuji

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.