Romvimza is a drug owned by Deciphera Pharmaceuticals Llc. It is protected by 3 US drug patents filed in 2025 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 Feb 03, 2040. 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. | |||
| US9181223 | 2-aminopyrimidin-6-ones and analogs exhibiting anti-cancer and anti-proliferative activities |
Mar, 2034
(8 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). | |||
| US11679110 | Methods of treating disorders using CSF1R inhibitors |
Feb, 2040
(14 years from now) | Active |
| US11103507 | Methods of treating disorders using CSF1R inhibitors |
Feb, 2040
(14 years from now) | Active |
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
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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 Feb 03, 2040 (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 Pharms 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 |
| 30MG | CAPSULE | Prescription | ORAL |
| 20MG | CAPSULE | Prescription | ORAL |