Vanrafia is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 7 US drug patents filed in 2025 out of which none have expired yet. Vanrafia's patents will be open to challenges from 02 April, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 16, 2040. Details of Vanrafia'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). | |||
| US11491137 | Methods of improving renal function |
Dec, 2040
(15 years from now) | Active |
| US11998526 | Methods of improving renal function |
Dec, 2040
(15 years from now) | Active |
| US12121509 | Methods of improving renal function |
Dec, 2040
(15 years from now) | Active |
| US10016393 | Stabilized pharmaceutical dosage forms comprising atrasentan |
Jul, 2034
(9 years from now) | Active |
| US9364458 | Stabilized pharmaceutical dosage forms comprising atrasentan |
Jul, 2034
(9 years from now) | Active |
| US11874283 | Method and compositions for the treatment and detection of endothelin-1 related kidney diseases |
Feb, 2032
(6 years from now) | Active |
| US8623819 | Therapy for complications of diabetes |
Aug, 2028
(3 years from now) | Active |
FDA has granted several exclusivities to Vanrafia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vanrafia, 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 Vanrafia.
Exclusivity Information
Vanrafia holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Vanrafia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 02, 2030 |
US patents provide insights into the exclusivity only within the United States, but Vanrafia 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 Vanrafia's family patents as well as insights into ongoing legal events on those patents.
Vanrafia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vanrafia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 16, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vanrafia Generics:
There are no approved generic versions for Vanrafia as of now.
Alternative Brands for Vanrafia
There are several other brand drugs in the same treatment category as Vanrafia. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Novartis |
| |||
About Vanrafia
Vanrafia is a drug owned by Novartis Pharmaceuticals Corp. Vanrafia uses Atrasentan Hydrochloride as an active ingredient. Vanrafia was launched by Novartis in 2025.
Approval Date:
Vanrafia was approved by FDA for market use on 02 April, 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 Vanrafia is 02 April, 2025, its NCE-1 date is estimated to be 02 April, 2029.
Active Ingredient:
Vanrafia uses Atrasentan Hydrochloride as the active ingredient. Check out other Drugs and Companies using Atrasentan Hydrochloride ingredient
Dosage:
Vanrafia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.75MG BASE | TABLET | Prescription | ORAL |