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: | 5,681 |
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 |
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 |
Generic filers with tentative approvals for ARMODAFINIL
Applicant | Application No. | Strength | Dosage Form |
⤷ Free Trial | ⤷ Free Trial | 250MG | TABLET;ORAL |
⤷ Free Trial | ⤷ Free Trial | 200MG | TABLET;ORAL |
⤷ Free Trial | ⤷ Free Trial | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs Inc | ARMODAFINIL | armodafinil | TABLET;ORAL | 200156-004 | Aug 29, 2012 | DISCN | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Mylan Pharms Inc | ARMODAFINIL | armodafinil | TABLET;ORAL | 200043-002 | Jun 1, 2012 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Corepharma | ARMODAFINIL | armodafinil | TABLET;ORAL | 201514-001 | Mar 25, 2019 | DISCN | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Natco Pharma Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 202768-003 | Nov 28, 2016 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Aurobindo Pharma Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 206069-001 | Mar 6, 2018 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
>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 | 021875-001 | Jun 15, 2007 | ⤷ Free Trial | ⤷ Free Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | ⤷ Free Trial | ⤷ Free Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | ⤷ Free Trial | ⤷ Free Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Free Trial | ⤷ Free Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Free Trial | ⤷ Free Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | ⤷ Free Trial | ⤷ Free Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for armodafinil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 200501016 | СПОСОБ ПОЛУЧЕНИЯ КРИСТАЛЛИЧЕСКИХ ФОРМ И КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ОПТИЧЕСКИХ ЭНАНТИОМЕРОВ МОДАФИНИЛА | ⤷ Free Trial |
World Intellectual Property Organization (WIPO) | 2004060858 | ⤷ Free Trial | |
China | 101012189 | Crystalline forms and crystalline forms of optical enantiomers of modafinil and method for the procution same | ⤷ Free Trial |
Argentina | 041242 | FORMULACIONES FARMACEUTICAS DE MODAFINIL Y PROCESOS PARA SU PREPARACION | ⤷ Free Trial |
Taiwan | I321475 | ⤷ Free Trial | |
Denmark | 2343275 | ⤷ Free Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory of Armodafinil
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