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

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Generated: September 23, 2019

DrugPatentWatch Database Preview

Armodafinil - Generic Drug Details

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

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 thirteen patent family members in thirty-one countries.

There are twelve drug master file entries for armodafinil. Twelve 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
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
Generic filers with tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up100MGTABLET;ORAL
➤ Sign Up➤ Sign Up50MGTABLET;ORAL
➤ Sign Up➤ Sign Up250MGTABLET;ORAL

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

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
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-003 Nov 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-005 Sep 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc ARMODAFINIL armodafinil TABLET;ORAL 201514-002 Mar 25, 2019 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
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-001 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

Expired US Patents for armodafinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021875-003 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 ➤ Sign Up ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 ➤ Sign Up ➤ Sign Up
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.