Voranigo is a drug owned by Servier Pharmaceuticals Llc. It is protected by 4 US drug patents filed in 2024 out of which none have expired yet. Voranigo's patents will be open to challenges from 06 August, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 16, 2039. Details of Voranigo'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. | |||
| US11345677 | Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same |
Jan, 2039
(14 years from now) | Active |
| US9579324 | Therapeutically active compounds and their methods of use |
Jul, 2034
(9 years from now) | Active |
| US10172864 | Therapeutically active compounds and their methods of use |
Jul, 2034
(9 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). | |||
| US11844758 | Therapeutically active compounds and their methods of use |
Dec, 2035
(11 years from now) | Active |
FDA has granted several exclusivities to Voranigo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Voranigo, 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 Voranigo.
Exclusivity Information
Voranigo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Voranigo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 06, 2029 |
| Orphan Drug Exclusivity(ODE-491) | Aug 06, 2031 |
US patents provide insights into the exclusivity only within the United States, but Voranigo 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 Voranigo's family patents as well as insights into ongoing legal events on those patents.
Voranigo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Voranigo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 16, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Voranigo Generics:
There are no approved generic versions for Voranigo as of now.
About Voranigo
Voranigo is a drug owned by Servier Pharmaceuticals Llc. Voranigo uses Vorasidenib as an active ingredient. Voranigo was launched by Servier in 2024.
Approval Date:
Voranigo was approved by FDA for market use on 06 August, 2024.
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 Voranigo is 06 August, 2024, its NCE-1 date is estimated to be 06 August, 2028.
Active Ingredient:
Voranigo uses Vorasidenib as the active ingredient. Check out other Drugs and Companies using Vorasidenib ingredient
Dosage:
Voranigo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |