Xromi is a drug owned by Nova Laboratories Ltd. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2041. Details of Xromi'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). | |||
| US12409156 | NA |
Dec, 2041
(16 years from now) | Active |
FDA has granted several exclusivities to Xromi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xromi, 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 Xromi.
Exclusivity Information
Xromi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Xromi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 04, 2027 |
| Orphan Drug Exclusivity(ODE-470) | Apr 04, 2031 |
US patents provide insights into the exclusivity only within the United States, but Xromi 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 Xromi's family patents as well as insights into ongoing legal events on those patents.
Xromi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xromi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xromi Generic API suppliers:
Hydroxyurea is the generic name for the brand Xromi. 6 different companies have already filed for the generic of Xromi, with Barr having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xromi's generic
About Xromi
Xromi is a drug owned by Nova Laboratories Ltd. Xromi uses Hydroxyurea as an active ingredient. Xromi was launched by Nova Labs Ltd in 2024.
Approval Date:
Xromi was approved by FDA for market use on 04 April, 2024.
Active Ingredient:
Xromi uses Hydroxyurea as the active ingredient. Check out other Drugs and Companies using Hydroxyurea ingredient
Dosage:
Xromi is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/ML | SOLUTION | Prescription | ORAL |