Lialda is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 26, 2023. Details of Lialda'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). | |||
| US6773720 | Mesalazine controlled release oral pharmaceutical compositions |
Jun, 2020
(4 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 Lialda's patents.
Latest Legal Activities on Lialda's Patents
Given below is the list of recent legal activities going on the following patents of Lialda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Review Certificate Mailed | 19 Mar, 2018 | US6773720 (Litigated) |
| Review Certificate | 01 Mar, 2018 | US6773720 (Litigated) |
| Termination or Final Written Decision | 05 Oct, 2016 | US6773720 (Litigated) |
| Request for Trial Granted Critical | 07 Oct, 2015 | US6773720 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 28 Mar, 2008 | US6773720 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 10 Aug, 2004 | US6773720 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 10 Aug, 2004 | US6773720 (Litigated) |
| Issue Notification Mailed Critical | 22 Jul, 2004 | US6773720 (Litigated) |
| Receipt into Pubs | 16 Jul, 2004 | US6773720 (Litigated) |
| Dispatch to FDC | 14 Jul, 2004 | US6773720 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lialda and ongoing litigations to help you estimate the early arrival of Lialda generic.
Lialda's Litigations
Lialda been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 01, 2015, against patent number US6773720. The petitioner Coalition For Affordable Drugs II LLC, challenged the validity of this patent, with Cosmo Technologies Ltd. et al. as the respondent. Click below to track the latest information on how companies are challenging Lialda's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6773720 | April, 2015 |
Final Written Decision
(05 Oct, 2016) | Cosmo Technologies Ltd. et al. | Coalition For Affordable Drugs II LLC |
FDA has granted some exclusivities to Lialda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lialda, 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 Lialda.
Exclusivity Information
Lialda holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Lialda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-640) | Jul 14, 2014 |
| New Patient Population(NPP) | Jun 26, 2023 |
US patents provide insights into the exclusivity only within the United States, but Lialda 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 Lialda's family patents as well as insights into ongoing legal events on those patents.
Lialda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lialda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 26, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lialda Generic API suppliers:
Mesalamine is the generic name for the brand Lialda. 21 different companies have already filed for the generic of Lialda, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lialda's generic
How can I launch a generic of Lialda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lialda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lialda'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 Lialda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.2 g | 16 Dec, 2009 | 1 | 05 Jun, 2017 | 08 Jun, 2020 | Deferred |
Alternative Brands for Lialda
There are several other brand drugs using the same active ingredient (Mesalamine) as Lialda. 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 | |||
|---|---|---|---|---|
| Abbvie |
| |||
| Apil |
| |||
| Mylan Speciality Lp |
| |||
| Salix |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mesalamine, Lialda's active ingredient. Check the complete list of approved generic manufacturers for Lialda
About Lialda
Lialda is a drug owned by Takeda Pharmaceuticals Usa Inc. Lialda uses Mesalamine as an active ingredient. Lialda was launched by Takeda Pharms Usa in 2007.
Approval Date:
Lialda was approved by FDA for market use on 16 January, 2007.
Active Ingredient:
Lialda uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Dosage:
Lialda is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.2GM | TABLET, DELAYED RELEASE | Prescription | ORAL |