Livmarli is a drug owned by Mirum Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2022 to 2024 out of which none have expired yet. Livmarli's patents will be open to challenges from 29 September, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 12, 2040. Details of Livmarli'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). | |||
| US11918578 | Methods for treating cholestasis |
Feb, 2040
(15 years from now) | Active |
| US11497745 | Methods for treating cholestasis |
Feb, 2040
(15 years from now) | Active |
| US11229647 | Methods for treating cholestasis |
Feb, 2040
(15 years from now) | Active |
| US10512657 | Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases |
Oct, 2032
(7 years from now) | Active |
| US11376251 | Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases |
Oct, 2032
(7 years from now) | Active |
| US11229661 | Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases |
Oct, 2032
(7 years from now) | Active |
| US11260053 | Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions |
May, 2031
(6 years 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 Livmarli's patents.
Latest Legal Activities on Livmarli's Patents
Given below is the list of recent legal activities going on the following patents of Livmarli.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 05 Mar, 2024 | US11918578 |
| Mail Patent eGrant Notification | 05 Mar, 2024 | US11918578 |
| Recordation of Patent eGrant | 05 Mar, 2024 | US11918578 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Mar, 2024 | US11918578 |
| Email Notification Critical | 05 Mar, 2024 | US11918578 |
| Patent eGrant Notification | 05 Mar, 2024 | US11918578 |
| Email Notification Critical | 15 Feb, 2024 | US11918578 |
| Issue Notification Mailed Critical | 14 Feb, 2024 | US11918578 |
| Dispatch to FDC | 03 Feb, 2024 | US11918578 |
| Application Is Considered Ready for Issue Critical | 03 Feb, 2024 | US11918578 |
FDA has granted several exclusivities to Livmarli. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Livmarli, 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 Livmarli.
Exclusivity Information
Livmarli holds 8 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Livmarli's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Mar 13, 2026 |
| New Chemical Entity Exclusivity(NCE) | Sep 29, 2026 |
| New Indication(I-938) | Mar 13, 2027 |
| Orphan Drug Exclusivity(ODE-379) | Sep 29, 2028 |
| Orphan Drug Exclusivity(ODE-429) | Mar 13, 2030 |
| ODE*(ODE*) | Mar 13, 2031 |
| Orphan Drug Exclusivity(ODE-471) | Mar 13, 2031 |
| Orphan Drug Exclusivity(ODE-490) | Jul 24, 2031 |
US patents provide insights into the exclusivity only within the United States, but Livmarli 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 Livmarli's family patents as well as insights into ongoing legal events on those patents.
Livmarli's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Livmarli's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 12, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Livmarli Generics:
There are no approved generic versions for Livmarli as of now.
About Livmarli
Livmarli is a drug owned by Mirum Pharmaceuticals Inc. It is used for treating cholestatic pruritus in patients with specific liver disorders. Livmarli uses Maralixibat Chloride as an active ingredient. Livmarli was launched by Mirum in 2021.
Can you believe Livmarli received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Livmarli was approved by FDA for market use on 29 September, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Livmarli is 29 September, 2021, its NCE-1 date is estimated to be 29 September, 2025.
Active Ingredient:
Livmarli uses Maralixibat Chloride as the active ingredient. Check out other Drugs and Companies using Maralixibat Chloride ingredient
Treatment:
Livmarli is used for treating cholestatic pruritus in patients with specific liver disorders.
Dosage:
Livmarli is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 9.5MG BASE/ML | SOLUTION | Prescription | ORAL |
| EQ 19MG BASE/ML | SOLUTION | Prescription | ORAL |