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Last Updated: January 30, 2023

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 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 sixteen patent family members in thirty-one countries.

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

Drug Prices for armodafinil

See drug prices for armodafinil

Recent Clinical Trials for armodafinil

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

SponsorPhase
Jazz PharmaceuticalsPhase 4
Charles Andrew Czeisler, MD, PhDPhase 4
University of FloridaPhase 1

See all armodafinil clinical trials

Generic filers with tentative approvals for ARMODAFINIL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing250MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing150MGTABLET;ORAL

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

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

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 202768-004 Sep 28, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-004 May 9, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Apotex Inc ARMODAFINIL armodafinil TABLET;ORAL 201514-003 Mar 25, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-004 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-003 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for armodafinil

Country Patent Number Title Estimated Expiration
Japan 2006501270 See Plans and Pricing
China 106065007 莫达非尼旋光对映异构体的晶形及其制备方法 (Crystalline forms of optical enantiomers of modafinil and method for the production) See Plans and Pricing
Brazil 0314515 See Plans and Pricing
Canada 2498506 NOUVELLES FORMULATIONS PHARMACEUTIQUES DU MODAFINIL (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL) See Plans and Pricing
Germany 60328119 See Plans and Pricing
Norway 20035211 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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 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.