Rivfloza is a drug owned by Novo Nordisk Inc. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Rivfloza's patents will be open to challenges from 30 September, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2038. Details of Rivfloza'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. | |||
| US11661604 | Methods and compositions for inhibiting expression of LDHA |
Oct, 2038
(13 years from now) | Active |
| US11286488 | Methods and compositions for inhibiting expression of LDHA |
Oct, 2038
(13 years from now) | Active |
| US11053502 | Therapeutic inhibition of lactate dehydrogenase and agents therefor |
Oct, 2035
(10 years from now) | Active |
| US10351854 | Therapeutic inhibition of lactate dehydrogenase and agents therefor |
Oct, 2035
(10 years from now) | Active |
| US11359203 | Therapeutic inhibition of lactate dehydrogenase and agents therefor |
Oct, 2035
(10 years from now) | Active |
| US10738311 | Therapeutic inhibition of lactate dehydrogenase and agents therefor |
Oct, 2035
(10 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 Rivfloza's patents.
Latest Legal Activities on Rivfloza's Patents
Given below is the list of recent legal activities going on the following patents of Rivfloza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eCofC Notification | 16 Jul, 2024 | US11286488 |
| Email Notification Critical | 16 Jul, 2024 | US11286488 |
| Patent eCofC Notification | 16 Jul, 2024 | US11286488 |
| Recordation of Patent eCertificate of Correction | 16 Jul, 2024 | US11286488 |
| Post Issue Communication - Certificate of Correction | 12 Jul, 2024 | US11661604 |
| Mail Pub Notice re 312 amendment | 01 Jul, 2024 | US11661604 |
| Email Notification Critical | 01 Jul, 2024 | US11661604 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 26 Jun, 2024 | US11661604 |
| Post Issue Communication - Certificate of Correction Denied | 26 Jun, 2024 | US11661604 |
| Post Issue Communication - Certificate of Correction | 25 Jun, 2024 | US11286488 |
FDA has granted several exclusivities to Rivfloza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rivfloza, 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 Rivfloza.
Exclusivity Information
Rivfloza holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Rivfloza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 29, 2028 |
| Orphan Drug Exclusivity(ODE-443) | Sep 29, 2030 |
US patents provide insights into the exclusivity only within the United States, but Rivfloza 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 Rivfloza's family patents as well as insights into ongoing legal events on those patents.
Rivfloza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rivfloza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rivfloza Generics:
There are no approved generic versions for Rivfloza as of now.
About Rivfloza
Rivfloza is a drug owned by Novo Nordisk Inc. It is used for treating Primary Hyperoxaluria Type 1 (PH1). Rivfloza uses Nedosiran Sodium as an active ingredient. Rivfloza was launched by Novo in 2023.
Approval Date:
Rivfloza was approved by FDA for market use on 29 September, 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 Rivfloza is 29 September, 2023, its NCE-1 date is estimated to be 30 September, 2027.
Active Ingredient:
Rivfloza uses Nedosiran Sodium as the active ingredient. Check out other Drugs and Companies using Nedosiran Sodium ingredient
Treatment:
Rivfloza is used for treating Primary Hyperoxaluria Type 1 (PH1).
Dosage:
Rivfloza is available in solution form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) | SOLUTION | Prescription | INJECTION |
| EQ 160MG BASE/ML (EQ 160MG BASE/ML) | SOLUTION | Prescription | INJECTION |
| EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | SOLUTION | Prescription | INJECTION |