Rezzayo is a drug owned by Mundipharma Gmbh. It is protected by 7 US drug patents filed in 2023 out of which none have expired yet. Rezzayo's patents will be open to challenges from 22 March, 2032. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 14, 2038. Details of Rezzayo'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. | |||
| US11197909 | Compositions and methods for the treatment of fungal infections |
Jul, 2038
(13 years from now) | Active |
| US11819533 | Compositions and methods for the treatment of fungal infections |
Jul, 2038
(13 years from now) | Active |
| US9526835 | Dosing regimens for echinocandin class compounds |
Mar, 2033
(7 years from now) | Active |
| US10702573 | Dosing regimens for echinocandin class compounds |
Mar, 2033
(7 years from now) | Active |
| US8722619 | Antifungal agents and uses thereof |
Mar, 2032
(6 years from now) | Active |
| US11654196 | Dosing regimens for echinocandin class compounds |
Mar, 2032
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11712459 | Dosing regimens for treatment of fungal infections |
Mar, 2037
(11 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 Rezzayo's patents.
Latest Legal Activities on Rezzayo's Patents
Given below is the list of recent legal activities going on the following patents of Rezzayo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Jun, 2024 | US9526835 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US8722619 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US9526835 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10702573 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10702573 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8722619 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US9526835 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 27 Dec, 2023 | US10702573 |
| Recordation of Patent Grant Mailed Critical | 21 Nov, 2023 | US11819533 |
| Patent eGrant Notification | 21 Nov, 2023 | US11819533 |
FDA has granted several exclusivities to Rezzayo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rezzayo, 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 Rezzayo.
Exclusivity Information
Rezzayo holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2033. Details of Rezzayo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 22, 2028 |
| Orphan Drug Exclusivity(ODE-426) | Mar 22, 2030 |
| Generating Antibiotic Incentives Now(GAIN) | Mar 22, 2033 |
US patents provide insights into the exclusivity only within the United States, but Rezzayo 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 Rezzayo's family patents as well as insights into ongoing legal events on those patents.
Rezzayo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rezzayo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 14, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rezzayo Generics:
There are no approved generic versions for Rezzayo as of now.
About Rezzayo
Rezzayo is a drug owned by Mundipharma Gmbh. It is used for treating candidemia and invasive candidiasis. Rezzayo uses Rezafungin Acetate as an active ingredient. Rezzayo was launched by Mundipharma in 2023.
Approval Date:
Rezzayo was approved by FDA for market use on 22 March, 2023.
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 Rezzayo is 22 March, 2023, its NCE-1 date is estimated to be 22 March, 2032.
Active Ingredient:
Rezzayo uses Rezafungin Acetate as the active ingredient. Check out other Drugs and Companies using Rezafungin Acetate ingredient
Treatment:
Rezzayo is used for treating candidemia and invasive candidiasis.
Dosage:
Rezzayo is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |