Provigil is a drug owned by Cephalon Llc. 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
(5 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
|
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 | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 200 mg |
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 | |
|---|---|---|
| Cephalon |
|
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 Cephalon Llc. It is used for treating excessive daytime sleepiness associated with narcolepsy. Provigil uses Modafinil as an active ingredient. Provigil was launched by Cephalon 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 |