Provigil is a drug owned by Nuvo Pharmaceuticals (ireland) Dac. It is protected by 4 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 May 29, 2024. Details of Provigil'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). | |||
|
US7297346 (Pediatric) | Pharmaceutical formulations of modafinil |
May, 2024
(1 year, 9 months ago) |
Expired
|
| US7297346 | Pharmaceutical formulations of modafinil |
Nov, 2023
(2 years ago) |
Expired
|
|
USRE37516 (Pediatric) | Acetamide derivative having defined particle size |
Apr, 2015
(10 years ago) |
Expired
|
| USRE37516 | Acetamide derivative having defined particle size |
Oct, 2014
(11 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 Provigil's patents.
Latest Legal Activities on Provigil's Patents
Given below is the list of recent legal activities going on the following patents of Provigil.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 23 Dec, 2019 | US7297346 (Litigated) |
| Maintenance Fee Reminder Mailed | 08 Jul, 2019 | US7297346 (Litigated) |
| Patent Issue Date Used in PTA Calculation | 20 Nov, 2007 | US7297346 (Litigated) |
| Recordation of Patent Grant Mailed | 20 Nov, 2007 | US7297346 (Litigated) |
| Issue Notification Mailed | 31 Oct, 2007 | US7297346 (Litigated) |
| Application Is Considered Ready for Issue | 16 Oct, 2007 | US7297346 (Litigated) |
| Dispatch to FDC | 16 Oct, 2007 | US7297346 (Litigated) |
| Issue Fee Payment Received | 05 Oct, 2007 | US7297346 (Litigated) |
| Issue Fee Payment Verified | 05 Oct, 2007 | US7297346 (Litigated) |
| Mail Miscellaneous Communication to Applicant | 31 Aug, 2007 | US7297346 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Provigil 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 Provigil's family patents as well as insights into
ongoing legal events
on those patents.
Provigil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Provigil's generic launch date based on the expiry of its last outstanding patent is estimated to be May 29, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Provigil Generic API suppliers:
Modafinil is the generic name for the brand Provigil. 9 different companies have already filed for the generic of Provigil, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Provigil's generic
How can I launch a generic of Provigil before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Provigil's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Provigil'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 Provigil -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None |
Alternative Brands for Provigil
Provigil which is used for treating excessive daytime sleepiness associated with narcolepsy., has several other brand drugs using the same active ingredient (Modafinil). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Nuvo Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Modafinil, Provigil's active ingredient. Check the complete list of approved generic manufacturers for Provigil
About Provigil
Provigil is a drug owned by Nuvo Pharmaceuticals (Ireland) Dac. It is used for treating excessive daytime sleepiness associated with narcolepsy. Provigil uses Modafinil as an active ingredient. Provigil was launched by Nuvo in 1998.
Approval Date:
Provigil was approved by FDA for market use on 24 December, 1998.
Active Ingredient:
Provigil uses Modafinil as the active ingredient. Check out other Drugs and Companies using Modafinil ingredient
Treatment:
Provigil is used for treating excessive daytime sleepiness associated with narcolepsy.
Dosage:
Provigil is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |