Armodafinil - Generic Drug Details

✉ Email this page to a colleague

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 Aurobindo Pharma Ltd, Corepharma, 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 sixteen 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 three tentative approvals for this compound.

Summary for armodafinil

International Patents:	116
US Patents:	2
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	59
Patent Applications:	5,770
Drug Prices:	Drug price trends for armodafinil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for armodafinil
What excipients (inactive ingredients) are in armodafinil?	armodafinil excipients list
DailyMed Link:	armodafinil at DailyMed

See drug prices for armodafinil

Recent Clinical Trials for armodafinil

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

Sponsor	Phase
Charles Andrew Czeisler, MD, PhD	Phase 4
Jazz Pharmaceuticals	Phase 4
University of Florida	Phase 1

See all armodafinil clinical trials

Generic filers with tentative approvals for ARMODAFINIL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	250MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	200MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	150MG	TABLET;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for armodafinil

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ARMODAFINIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVIGIL	Tablets	armodafinil	100 mg	021875	1	2009-09-08
NUVIGIL	Tablets	armodafinil	200 mg	021875	1	2009-09-03
NUVIGIL	Tablets	armodafinil	50 mg, 150 mg and 250 mg	021875	1	2009-07-24

US Patents and Regulatory Information for armodafinil

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corepharma	ARMODAFINIL	armodafinil	TABLET;ORAL	201514-002	Mar 25, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	ARMODAFINIL	armodafinil	TABLET;ORAL	200156-004	Aug 29, 2012		DISCN	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
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	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	021875-004	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for armodafinil

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	02096401		⤷ Sign Up
Japan	4719471		⤷ Sign Up
Eurasian Patent Organization	008506	НОВЫЕ ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ МОДАФИНИЛА (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.