Rezdiffra is a drug owned by Madrigal Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2024 out of which none have expired yet. Rezdiffra's patents will be open to challenges from 14 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2033. Details of Rezdiffra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9266861 | Method of synthesizing thyroid hormone analogs and polymorphs thereof |
Sep, 2033
(8 years from now) | Active |
| US11564926 | Methods of synthesizing thyroid hormone analogs and polymorphs thereof |
Sep, 2033
(8 years from now) | Active |
| US7452882 | Thyroid hormone analogs |
Sep, 2026
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11986481 | Method of synthesizing thyroid hormone analogs and polymorphs thereof |
Sep, 2033
(8 years from now) | Active |
| US10376517 | Methods of synthesizing thyroid hormone analogs and polymorphs thereof |
Sep, 2033
(8 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 Rezdiffra's patents.
Latest Legal Activities on Rezdiffra's Patents
Given below is the list of recent legal activities going on the following patents of Rezdiffra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Jun, 2024 | US7452882 |
| Email Notification Critical | 26 Jun, 2024 | US7452882 |
| Initial letter Re: PTE Application to regulating agency | 07 May, 2024 | US7452882 |
| Initial letter Re: PTE Application to regulating agency | 07 May, 2024 | US9266861 |
| Requirement for information sent under 37 CFR 1.750 | 07 May, 2024 | US7452882 |
| Patent Term Extension Application under 35 USC 156 Filed | 02 May, 2024 | US7452882 |
| Patent Term Extension Application under 35 USC 156 Filed | 02 May, 2024 | US9266861 |
| Email Notification Critical | 17 Apr, 2024 | US7452882 |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Apr, 2024 | US7452882 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Apr, 2024 | US9266861 |
FDA has granted several exclusivities to Rezdiffra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rezdiffra, 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 Rezdiffra.
Exclusivity Information
Rezdiffra holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Rezdiffra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 14, 2029 |
US patents provide insights into the exclusivity only within the United States, but Rezdiffra 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 Rezdiffra's family patents as well as insights into ongoing legal events on those patents.
Rezdiffra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rezdiffra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 17, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rezdiffra Generics:
There are no approved generic versions for Rezdiffra as of now.
About Rezdiffra
Rezdiffra is a drug owned by Madrigal Pharmaceuticals Inc. It is used for treating adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis. Rezdiffra uses Resmetirom as an active ingredient. Rezdiffra was launched by Madrigal in 2024.
Approval Date:
Rezdiffra was approved by FDA for market use on 14 March, 2024.
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 Rezdiffra is 14 March, 2024, its NCE-1 date is estimated to be 14 March, 2028.
Active Ingredient:
Rezdiffra uses Resmetirom as the active ingredient. Check out other Drugs and Companies using Resmetirom ingredient
Treatment:
Rezdiffra is used for treating adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
Dosage:
Rezdiffra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 60MG | TABLET | Prescription | ORAL |