Lysteda Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8273795 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US8487005 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US8957113 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US8809394 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US9060939 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US7947739 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US8022106 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active
US8791160 Tranexamic acid formulations
Mar, 2025

(7 months from now)

Active


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

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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

Lysteda has patent protection in a total of 2 countries. It has a significant patent presence in the US with 82.6% of its patents being US patents. Click below to unlock the full patent family tree for Lysteda.

Family Patents

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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 Generics:

Tranexamic Acid is the generic name for the brand Lysteda. 24 different companies have already filed for the generic of Lysteda, with Epic Pharma Llc 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.

Market Authorisation 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