Ryzolt is a drug owned by Purdue Pharma Products Lp. 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 Oct 27, 2023. Details of Ryzolt'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). | |||
| US7988998 | Sustained-release tramadol formulations with 24-hour efficacy |
Oct, 2023
(1 year, 2 months ago) |
Expired
|
| US6607748 | Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture |
Jun, 2020
(4 years ago) |
Expired
|
| US5591452 | Controlled release formulation |
May, 2014
(10 years ago) |
Expired
|
| US6254887 | Controlled release tramadol |
May, 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 Ryzolt's patents.
Latest Legal Activities on Ryzolt's Patents
Given below is the list of recent legal activities going on the following patents of Ryzolt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US7988998 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2019 | US7988998 |
| Recordation of Patent Grant Mailed Critical | 02 Aug, 2011 | US7988998 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Aug, 2011 | US7988998 |
| Email Notification Critical | 14 Jul, 2011 | US7988998 |
| Issue Notification Mailed Critical | 13 Jul, 2011 | US7988998 |
| Email Notification Critical | 30 Jun, 2011 | US7988998 |
| Mail Miscellaneous Communication to Applicant | 30 Jun, 2011 | US7988998 |
| Dispatch to FDC | 29 Jun, 2011 | US7988998 |
| Application Is Considered Ready for Issue Critical | 27 Jun, 2011 | US7988998 |
FDA has granted several exclusivities to Ryzolt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ryzolt, 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 Ryzolt.
Exclusivity Information
Ryzolt holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Ryzolt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 30, 2011 |
US patents provide insights into the exclusivity only within the United States, but Ryzolt 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 Ryzolt's family patents as well as insights into ongoing legal events on those patents.
Ryzolt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ryzolt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 27, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ryzolt Generic API suppliers:
Tramadol Hydrochloride is the generic name for the brand Ryzolt. 28 different companies have already filed for the generic of Ryzolt, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ryzolt's generic
How can I launch a generic of Ryzolt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ryzolt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ryzolt'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 Ryzolt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg, 200 mg and 300 mg | 18 Jun, 2009 | 1 | 30 Dec, 2011 | 29 Jun, 2020 | Eligible |
Alternative Brands for Ryzolt
There are several other brand drugs using the same active ingredient (Tramadol Hydrochloride) as Ryzolt. 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 | |
|---|---|---|
| Athena |
| |
| Cipher Pharms Inc |
| |
| Janssen Pharms |
| |
| Kowa Pharms |
| |
| Shionogi Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tramadol Hydrochloride, Ryzolt's active ingredient. Check the complete list of approved generic manufacturers for Ryzolt
About Ryzolt
Ryzolt is a drug owned by Purdue Pharma Products Lp. Ryzolt uses Tramadol Hydrochloride as an active ingredient. Ryzolt was launched by Purdue Pharma in 2008.
Approval Date:
Ryzolt was approved by FDA for market use on 30 December, 2008.
Active Ingredient:
Ryzolt uses Tramadol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tramadol Hydrochloride ingredient
Dosage:
Ryzolt is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |