Intermezzo is a drug owned by Purdue Pharma Products Lp. It is protected by 4 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 20, 2029. Details of Intermezzo'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). | |||
| US8242131 | Methods of treating middle-of-the-night insomnia |
Aug, 2029
(4 years from now) | Active |
| US7658945 | Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof |
Apr, 2027
(2 years from now) | Active |
| US8252809 | Compositions for treating insomnia |
Feb, 2025
(a month from now) | Active |
| US7682628 | Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof |
Feb, 2025
(a month from now) | Active |
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 Intermezzo's patents.
Latest Legal Activities on Intermezzo's Patents
Given below is the list of recent legal activities going on the following patents of Intermezzo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 25 Apr, 2022 | US7682628 |
| Expire Patent Critical | 14 Mar, 2022 | US7658945 |
| Maintenance Fee Reminder Mailed Critical | 08 Nov, 2021 | US7682628 |
| Maintenance Fee Reminder Mailed Critical | 27 Sep, 2021 | US7658945 |
| Expire Patent Critical | 05 Oct, 2020 | US8252809 |
| Expire Patent Critical | 21 Sep, 2020 | US8242131 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 20 Apr, 2020 | US8252809 |
| Maintenance Fee Reminder Mailed Critical | 06 Apr, 2020 | US8242131 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Aug, 2017 | US7682628 |
| Post Issue Communication - Certificate of Correction | 23 Jan, 2017 | US8242131 (Litigated) |
FDA has granted several exclusivities to Intermezzo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Intermezzo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Intermezzo.
Exclusivity Information
Intermezzo holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Intermezzo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 23, 2014 |
US patents provide insights into the exclusivity only within the United States, but Intermezzo 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 Intermezzo's family patents as well as insights into ongoing legal events on those patents.
Intermezzo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Intermezzo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 20, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Intermezzo Generic API suppliers:
Zolpidem Tartrate is the generic name for the brand Intermezzo. 30 different companies have already filed for the generic of Intermezzo, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Intermezzo's generic
How can I launch a generic of Intermezzo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Intermezzo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Intermezzo'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 Intermezzo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.75 mg and 3.5 mg | 10 Apr, 2012 | 1 | 03 Jun, 2015 | 15 Apr, 2027 | Eligible |
Alternative Brands for Intermezzo
Intermezzo which is used for treating insomnia, specifically middle-of-the-night insomnia., has several other brand drugs using the same active ingredient (Zolpidem Tartrate). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolpidem Tartrate, Intermezzo's active ingredient. Check the complete list of approved generic manufacturers for Intermezzo
About Intermezzo
Intermezzo is a drug owned by Purdue Pharma Products Lp. It is used for treating insomnia, specifically middle-of-the-night insomnia. Intermezzo uses Zolpidem Tartrate as an active ingredient. Intermezzo was launched by Purdue Pharma in 2011.
Approval Date:
Intermezzo was approved by FDA for market use on 23 November, 2011.
Active Ingredient:
Intermezzo uses Zolpidem Tartrate as the active ingredient. Check out other Drugs and Companies using Zolpidem Tartrate ingredient
Treatment:
Intermezzo is used for treating insomnia, specifically middle-of-the-night insomnia.
Dosage:
Intermezzo is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.75MG | TABLET | Discontinued | SUBLINGUAL |
| 3.5MG | TABLET | Discontinued | SUBLINGUAL |