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 Cephalon and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and sixteen patent family members in thirty-one countries.
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
International Patents: | 116 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 32 |
Patent Applications: | 4,235 |
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 |
![NUVIGIL drug patent expirations Drug patent expirations by year for NUVIGIL](/p/graph/s/t/NUVIGIL-patent-expirations.png)
![Drug Prices for NUVIGIL](/p/graph/drug-price/NUVIGIL.png)
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ 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 | |||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | DISCN | Yes | No | ⤷ 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 | |||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | AB | RX | Yes | 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 NUVIGIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | 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 | 021875-002 | Mar 26, 2009 | ⤷ 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 |
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | 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 NUVIGIL
See the table below for patents covering NUVIGIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
United Kingdom | 2293103 | Modafinil composition of defined particle size | ⤷ Sign Up |
European Patent Office | 2676952 | Procédé de préparation et formes cristallines IV des énantiomères optiques du modafinil (Preparation method and crystalline form IV of optical enantiomers of modafinil) | ⤷ Sign Up |
Japan | 2006511588 | ⤷ Sign Up | |
Bulgaria | 62952 | ⤷ Sign Up | |
Slovakia | 44597 | PHARMACEUTICAL COMPOSITION CONTAINING MODAFINIL HAVING DEFINED PARTICLE SIZE | ⤷ Sign Up |
South Korea | 20040005986 | ⤷ Sign Up | |
Japan | 2004532863 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |