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. Fourteen 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.
Summary for NUVIGIL
| International Patents: | 116 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 35 |
| Clinical Trials: | 32 |
| Patent Applications: | 4,330 |
| Formulation / Manufacturing: | see details |
| 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 |
| University of Pennsylvania | N/A |
| Teva Pharmaceutical Industries, Ltd. | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for NUVIGIL
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 NUVIGIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | ⤷ 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 | 021875-003 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Argentina | 033910 | NUEVAS FORMULACIONES FARMACEUTICAS DE MODA-FINIL | ⤷ Try a Trial |
| China | 101914044 | Crystalline forms of optical enantiomers of modafinil and method for the production | ⤷ Try a Trial |
| New Zealand | 295869 | MONAFINIL COMPOSITION IN PARTICULATE FORM HAVING A PARTICLE DIAMETER OF LESS THAN 200 MICRONS | ⤷ Try a Trial |
| >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.
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