Nuvigil is a drug owned by Cephalon Inc. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 18, 2024. Details of Nuvigil's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7132570 (Pediatric) | Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil |
Jun, 2024
(4 months ago) |
Expired
|
|
US7297346 (Pediatric) | Pharmaceutical formulations of modafinil |
May, 2024
(5 months ago) |
Expired
|
| US7132570 | Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil |
Dec, 2023
(10 months ago) |
Expired
|
| US7297346 | Pharmaceutical formulations of modafinil |
Nov, 2023
(11 months ago) |
Expired
|
|
USRE37516 (Pediatric) | Acetamide derivative having defined particle size |
Apr, 2015
(9 years ago) |
Expired
|
| USRE37516 | Acetamide derivative having defined particle size |
Oct, 2014
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nuvigil's patents.
Latest Legal Activities on Nuvigil's Patents
Given below is the list of recent legal activities going on the following patents of Nuvigil.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 23 Dec, 2019 | US7297346 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Jul, 2019 | US7297346 (Litigated) |
| Expire Patent Critical | 10 Dec, 2018 | US7132570 |
| Maintenance Fee Reminder Mailed Critical | 18 Jun, 2018 | US7132570 |
| Correspondence Address Change Critical | 05 Jan, 2010 | US7132570 |
| Recordation of Patent Grant Mailed Critical | 20 Nov, 2007 | US7297346 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 20 Nov, 2007 | US7297346 (Litigated) |
| Issue Notification Mailed Critical | 31 Oct, 2007 | US7297346 (Litigated) |
| Application Is Considered Ready for Issue Critical | 16 Oct, 2007 | US7297346 (Litigated) |
| Dispatch to FDC | 16 Oct, 2007 | US7297346 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Nuvigil is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nuvigil's family patents as well as insights into ongoing legal events on those patents.
Nuvigil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nuvigil's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 18, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuvigil Generic API suppliers:
Armodafinil is the generic name for the brand Nuvigil. 6 different companies have already filed for the generic of Nuvigil, with Mylan Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nuvigil's generic
How can I launch a generic of Nuvigil before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nuvigil's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nuvigil's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Nuvigil -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg, 150 mg and 250 mg | 24 Jul, 2009 | 1 | 01 Jun, 2012 | 18 Dec, 2024 | Eligible |
| 100 mg | 08 Sep, 2009 | 1 | 18 Dec, 2023 | Extinguished | |
| 200 mg | 03 Sep, 2009 | 1 | 18 Dec, 2023 | Extinguished |
About Nuvigil
Nuvigil is a drug owned by Cephalon Inc. It is used for promoting wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Nuvigil uses Armodafinil as an active ingredient. Nuvigil was launched by Cephalon in 2007.
Approval Date:
Nuvigil was approved by FDA for market use on 15 June, 2007.
Active Ingredient:
Nuvigil uses Armodafinil as the active ingredient. Check out other Drugs and Companies using Armodafinil ingredient
Treatment:
Nuvigil is used for promoting wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Dosage:
Nuvigil is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 250MG | TABLET | Prescription | ORAL |
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |