Revuforj is a drug owned by Syndax Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Revuforj's patents will be open to challenges from 15 November, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2037. Details of Revuforj'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. | |||
| US10683302 | Inhibitors of the menin-MLL interaction |
Jun, 2037
(12 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). | |||
| US11479557 | Inhibitors of the menin-MLL interaction |
Jun, 2037
(12 years from now) | Active |
FDA has granted several exclusivities to Revuforj. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Revuforj, 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 Revuforj.
Exclusivity Information
Revuforj holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Revuforj's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2029 |
| Orphan Drug Exclusivity(ODE-502) | Nov 15, 2031 |
US patents provide insights into the exclusivity only within the United States, but Revuforj 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 Revuforj's family patents as well as insights into ongoing legal events on those patents.
Revuforj's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Revuforj's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 08, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Revuforj Generics:
There are no approved generic versions for Revuforj as of now.
About Revuforj
Revuforj is a drug owned by Syndax Pharmaceuticals Inc. Revuforj uses Revumenib Citrate as an active ingredient. Revuforj was launched by Syndax in 2024.
Approval Date:
Revuforj was approved by FDA for market use on 15 November, 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 Revuforj is 15 November, 2024, its NCE-1 date is estimated to be 15 November, 2028.
Active Ingredient:
Revuforj uses Revumenib Citrate as the active ingredient. Check out other Drugs and Companies using Revumenib Citrate ingredient
Dosage:
Revuforj is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 160MG BASE | TABLET | Prescription | ORAL |
| EQ 110MG BASE | TABLET | Prescription | ORAL |