Lysteda is a drug owned by Amring Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 04, 2025. Details of Lysteda'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). | |||
| US8022106 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US8273795 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US8487005 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US8791160 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US8957113 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US8809394 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US9060939 | Tranexamic acid formulations |
Mar, 2025
(2 months from now) | Active |
| US7947739 | Tranexamic acid formulations |
Mar, 2025
(2 months 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 Lysteda's patents.
Latest Legal Activities on Lysteda's Patents
Given below is the list of recent legal activities going on the following patents of Lysteda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Nov, 2023 | US8273795 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 04 Nov, 2022 | US8022106 (Litigated) |
| Correspondence Address Change Critical | 18 Oct, 2022 | US8487005 |
| Correspondence Address Change Critical | 18 Oct, 2022 | US8809394 |
| Correspondence Address Change Critical | 18 Oct, 2022 | US8273795 |
| Correspondence Address Change Critical | 18 Oct, 2022 | US8022106 (Litigated) |
| Correspondence Address Change Critical | 18 Oct, 2022 | US8791160 |
| Correspondence Address Change Critical | 18 Oct, 2022 | US9060939 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Aug, 2022 | US7947739 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Aug, 2022 | US9060939 |
FDA has granted several exclusivities to Lysteda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lysteda, 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 Lysteda.
Exclusivity Information
Lysteda holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Lysteda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Nov 13, 2012 |
US patents provide insights into the exclusivity only within the United States, but Lysteda 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 Lysteda's family patents as well as insights into ongoing legal events on those patents.
Lysteda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lysteda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 04, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lysteda Generic API suppliers:
Tranexamic Acid is the generic name for the brand Lysteda. 25 different companies have already filed for the generic of Lysteda, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lysteda's generic
How can I launch a generic of Lysteda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lysteda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lysteda'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 Lysteda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 650 mg | 24 May, 2011 | 2 | 27 Dec, 2012 | 04 Mar, 2025 | Eligible |
About Lysteda
Lysteda is a drug owned by Amring Pharmaceuticals Inc. It is used for treating cyclic heavy menstrual bleeding. Lysteda uses Tranexamic Acid as an active ingredient. Lysteda was launched by Amring Pharms in 2009.
Approval Date:
Lysteda was approved by FDA for market use on 13 November, 2009.
Active Ingredient:
Lysteda uses Tranexamic Acid as the active ingredient. Check out other Drugs and Companies using Tranexamic Acid ingredient
Treatment:
Lysteda is used for treating cyclic heavy menstrual bleeding.
Dosage:
Lysteda is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 650MG | TABLET | Prescription | ORAL |