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 | Stable Aqueous Hydroxycarbamide Solution |
Dec, 2041
(15 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 Xromi's patents.
Latest Legal Activities on Xromi's Patents
Given below is the list of recent legal activities going on the following patents of Xromi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 16 Sep, 2025 | US12409156 |
| Mail Patent eGrant Notification | 09 Sep, 2025 | US12409156 |
| Recordation of Patent eGrant | 09 Sep, 2025 | US12409156 |
| Patent Issue Date Used in PTA Calculation | 09 Sep, 2025 | US12409156 |
| Patent eGrant Notification | 09 Sep, 2025 | US12409156 |
| Email Notification | 09 Sep, 2025 | US12409156 |
| Email Notification | 28 Aug, 2025 | US12409156 |
| Issue Notification Mailed | 27 Aug, 2025 | US12409156 |
| Application Is Considered Ready for Issue | 20 Aug, 2025 | US12409156 |
| Dispatch to FDC | 20 Aug, 2025 | US12409156 |
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
Clinical Trials
Recent Clinical Trials on Xromi:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 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 |