NUVIGIL Drug Patent Profile
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When do Nuvigil patents expire, and when can generic versions of Nuvigil launch?
Nuvigil is a drug marketed by Nuvo Pharms and is included in one NDA.
The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nuvigil
A generic version of NUVIGIL was approved as armodafinil by MYLAN PHARMS INC on June 1st, 2012.
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Questions you can ask:
- What is the 5 year forecast for NUVIGIL?
- What are the global sales for NUVIGIL?
- What is Average Wholesale Price for NUVIGIL?
Summary for NUVIGIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 32 |
Patent Applications: | 4,464 |
Drug Prices: | Drug price information for NUVIGIL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUVIGIL |
What excipients (inactive ingredients) are in NUVIGIL? | NUVIGIL excipients list |
DailyMed Link: | NUVIGIL at DailyMed |


Recent Clinical Trials for NUVIGIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | Phase 1 |
Teva Pharmaceutical Industries, Ltd. | N/A |
University of Pennsylvania | N/A |
Paragraph IV (Patent) Challenges for NUVIGIL
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 NUVIGIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 NUVIGIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | ⤷ Try for Free | ⤷ Try for Free |
Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUVIGIL
See the table below for patents covering NUVIGIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 377196 | Sposób przygotowania i postacie krystaliczne enancjomerów optycznych modafinilu (METHOD FOR THE PRODUCTION OF CRYSTALLINE FORMS AND CRYSTALLINE FORMS OF OPTICAL ENANTIOMERS OF MODAFINIL) | ⤷ Try for Free |
Chile | 2016002640 | Procedimiento de preparación y formas cristalinas de los enantiómeros ópticos de modafinilo (divisional solicitud de origen 2693-2003). | ⤷ Try for Free |
European Patent Office | 1556026 | NOUVELLES FORMULATIONS PHARMACEUTIQUES DU MODAFINIL (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for NUVIGIL (Armodafinil)
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