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 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	50MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	250MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	200MG	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	200751-003	Nov 28, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	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
Corepharma	ARMODAFINIL	armodafinil	TABLET;ORAL	201514-001	Mar 25, 2019		DISCN	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

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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	021875-003	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	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

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Country	Patent Number	Title	Estimated Expiration
South Africa	200309978	SOLID PHARMACEUTICAL FORMULATIONS COMPRISING MODAFINIL	⤷ Sign Up
Hong Kong	1225371	莫達非尼旋光對映異構體的晶形及其製備方法 (METHOD FOR THE PRODUCTION OF CRYSTALLINE FORMS AND CRYSTALLINE FORMS OF OPTICAL ENANTIOMERS OF MODAFINIL)	⤷ Sign Up
Germany	60328119		⤷ Sign Up
Japan	2011102330	METHOD FOR PREPARATION OF MODAFINIL ENANTIOMER AND CRYSTAL FORM	⤷ Sign Up
Taiwan	I316406		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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