Romvimza is a drug owned by Deciphera Pharmaceuticals Llc. It is protected by 9 US drug patents filed from 2025 to 2026 out of which none have expired yet. Romvimza's patents will be open to challenges from 14 February, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 30, 2045. Details of Romvimza'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. | |||
| US12528787 | NA |
Dec, 2044
(18 years from now) | Active |
| US9181223 | 2-aminopyrimidin-6-ones and analogs exhibiting anti-cancer and anti-proliferative activities |
Mar, 2034
(7 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). | |||
| US12509443 | Csf-1R Inhibitors And Methods Of Use Thereof |
Apr, 2045
(19 years from now) | Active |
| US12447149 | Formulations Of Vimseltinib |
Dec, 2044
(18 years from now) | Active |
| US12551483 | NA |
Dec, 2044
(18 years from now) | Active |
| US11103507 | Methods of treating disorders using CSF1R inhibitors |
Feb, 2040
(13 years from now) | Active |
| US11679110 | Methods of treating disorders using CSF1R inhibitors |
Feb, 2040
(13 years from now) | Active |
| US12485120 | Methods Of Treating Disorders Using Csf1R Inhibitors |
Dec, 2039
(13 years from now) | Active |
| US12285430 | Methods of treating disorders using CSF1R inhibitors |
Dec, 2039
(13 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 Romvimza's patents.
Latest Legal Activities on Romvimza's Patents
Given below is the list of recent legal activities going on the following patents of Romvimza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Application Dispatched from OIPE | 17 Sep, 2025 | US12509443 |
| Mail Notice of Allowance | 16 Sep, 2025 | US12528787 |
| Application Is Considered Ready for Issue | 16 Sep, 2025 | US12447149 |
| Dispatch to FDC | 16 Sep, 2025 | US12447149 |
| Notice of Allowance Data Verification Completed | 13 Sep, 2025 | US12528787 |
| Mail Notice of Allowance | 11 Sep, 2025 | US12447149 |
| Issue Fee Payment Received | 11 Sep, 2025 | US12447149 |
| Issue Fee Payment Verified | 11 Sep, 2025 | US12447149 |
| Information Disclosure Statement (IDS) Filed | 10 Sep, 2025 | US12509443 |
| Email Notification | 08 Sep, 2025 | US12509443 |
FDA has granted several exclusivities to Romvimza. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Romvimza, 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
Romvimza.
Exclusivity Information
Romvimza holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Romvimza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 14, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Romvimza 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 Romvimza's family patents as well as insights into
ongoing legal events
on those patents.
Romvimza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Romvimza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 30, 2045 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Romvimza Generics:
There are no approved generic versions for Romvimza as of now.
About Romvimza
Romvimza is a drug owned by Deciphera Pharmaceuticals Llc. Romvimza uses Vimseltinib as an active ingredient. Romvimza was launched by Deciphera in 2025.
Approval Date:
Romvimza was approved by FDA for market use on 14 February, 2025.
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 Romvimza is 14 February, 2025, its NCE-1 date is estimated to be 14 February, 2029.
Active Ingredient:
Romvimza uses Vimseltinib as the active ingredient. Check out other Drugs and Companies using Vimseltinib ingredient
Dosage:
Romvimza is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 14MG | CAPSULE | Prescription | ORAL |
| 20MG | CAPSULE | Prescription | ORAL |
| 30MG | CAPSULE | Prescription | ORAL |