Rozerem is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 2 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 16, 2021. Details of Rozerem'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). | |||
| US10098866 | Pharmaceutical preparation containing copolyvidone |
Nov, 2021
(3 years ago) |
Expired
|
| US6034239 | Tricyclic compounds, their production and use |
Jul, 2019
(5 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 Rozerem's patents.
Latest Legal Activities on Rozerem's Patents
Given below is the list of recent legal activities going on the following patents of Rozerem.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 21 Nov, 2022 | US10098866 |
| Maintenance Fee Reminder Mailed Critical | 06 Jun, 2022 | US10098866 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Oct, 2018 | US10098866 |
| Recordation of Patent Grant Mailed Critical | 16 Oct, 2018 | US10098866 |
| Email Notification Critical | 27 Sep, 2018 | US10098866 |
| Issue Notification Mailed Critical | 26 Sep, 2018 | US10098866 |
| Dispatch to FDC | 17 Sep, 2018 | US10098866 |
| Application Is Considered Ready for Issue Critical | 15 Sep, 2018 | US10098866 |
| Issue Fee Payment Received Critical | 11 Sep, 2018 | US10098866 |
| Issue Fee Payment Verified Critical | 11 Sep, 2018 | US10098866 |
FDA has granted several exclusivities to Rozerem. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rozerem, 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 Rozerem.
Exclusivity Information
Rozerem holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Rozerem's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-82) | Oct 20, 2011 |
US patents provide insights into the exclusivity only within the United States, but Rozerem 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 Rozerem's family patents as well as insights into ongoing legal events on those patents.
Rozerem's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rozerem's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 16, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rozerem Generic API suppliers:
Ramelteon is the generic name for the brand Rozerem. 10 different companies have already filed for the generic of Rozerem, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rozerem's generic
How can I launch a generic of Rozerem before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rozerem's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rozerem'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 Rozerem -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8 mg | 22 Jul, 2009 | 2 | 26 Jul, 2013 | 22 Jul, 2019 | Deferred |
Alternative Brands for Rozerem
Rozerem which is used for treating insomnia., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Mylan Speciality Lp |
| |||
About Rozerem
Rozerem is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating insomnia. Rozerem uses Ramelteon as an active ingredient. Rozerem was launched by Takeda Pharms Usa in 2005.
Approval Date:
Rozerem was approved by FDA for market use on 22 July, 2005.
Active Ingredient:
Rozerem uses Ramelteon as the active ingredient. Check out other Drugs and Companies using Ramelteon ingredient
Treatment:
Rozerem is used for treating insomnia.
Dosage:
Rozerem is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 8MG | TABLET | Prescription | ORAL |