Rhapsido is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed in 2025 out of which none have expired yet. Rhapsido's patents will be open to challenges from 30 September, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 20, 2043. Details of Rhapsido'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. | |||
| US9512084 | NA |
Nov, 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). | |||
| US12419889 | NA |
Jan, 2043
(17 years from now) | Active |
| US10457647 | NA |
Nov, 2034
(8 years from now) | Active |
FDA has granted several exclusivities to Rhapsido. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Rhapsido, 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
Rhapsido.
Exclusivity Information
Rhapsido holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Rhapsido's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 30, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Rhapsido 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 Rhapsido's family patents as well as insights into
ongoing legal events
on those patents.
Rhapsido's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rhapsido's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 20, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rhapsido Generics:
There are no approved generic versions for Rhapsido as of now.
About Rhapsido
Rhapsido is a drug owned by Novartis Pharmaceuticals Corp. Rhapsido uses Remibrutinib as an active ingredient. Rhapsido was launched by Novartis in 2025.
Approval Date:
Rhapsido was approved by FDA for market use on 30 September, 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 Rhapsido is 30 September, 2025, its NCE-1 date is estimated to be 30 September, 2029.
Active Ingredient:
Rhapsido uses Remibrutinib as the active ingredient. Check out other Drugs and Companies using Remibrutinib ingredient
Dosage:
Rhapsido is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Prescription | ORAL |