Armodafinil - Generic Drug Details
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What are the generic drug 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 |
Formulation / Manufacturing: | see details |
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 |
⤷ Try a Trial | ⤷ Try a Trial | 250MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 200MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Pharms Inc | ARMODAFINIL | armodafinil | TABLET;ORAL | 200043-001 | Jun 1, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | Jun 15, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs Inc | ARMODAFINIL | armodafinil | TABLET;ORAL | 200156-002 | Aug 29, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 021875-003 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for armodafinil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2016002640 | Procedimiento de preparación y formas cristalinas de los enantiómeros ópticos de modafinilo (divisional solicitud de origen 2693-2003). | ⤷ Try a Trial |
France | 2849029 | PROCEDE DE PREPARATION ET FORMES CRISTALLINES DES ENANTIOMERES OPTIQUES DU MODAFINIL. (Production of new or known crystalline forms of enantiomers of modafinil, useful e.g. for treating hypersomnia and stimulating cognition, by crystallization from solvents other than ethanol) | ⤷ Try a Trial |
New Zealand | 540733 | Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |