Fotivda is a drug owned by Aveo Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2021 to 2022. Out of these, 2 drug patents are active and 1 has expired. Fotivda's patents have been open to challenges since 10 March, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 05, 2039. Details of Fotivda'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. | |||
| US7166722 | N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n′-(5-methyl-3-isoxazolyl)urea salt in crystalline form |
Nov, 2028
(3 years from now) | Active |
| US6821987 | Quinoline derivatives and quinazoline derivatives having azolyl group |
Apr, 2025
(2 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11504365 | Use of tivozanib to treat subjects with refractory cancer |
Nov, 2039
(14 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 Fotivda's patents.
Latest Legal Activities on Fotivda's Patents
Given below is the list of recent legal activities going on the following patents of Fotivda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Interim Patent Term Extension Granted Critical | 18 Mar, 2024 | US6821987 |
| transaction for FDA Determination of Regulatory Review Period | 28 Dec, 2023 | US6821987 |
| transaction for FDA Determination of Regulatory Review Period | 28 Dec, 2023 | US7166722 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US6821987 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US7166722 |
| Interim Patent Term Extension Granted Critical | 05 Oct, 2023 | US7166722 |
| Electronic Review Critical | 15 Aug, 2023 | US7166722 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 Aug, 2023 | US7166722 |
| Email Notification Critical | 15 Aug, 2023 | US7166722 |
| Email Notification Critical | 14 Aug, 2023 | US6821987 |
FDA has granted several exclusivities to Fotivda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fotivda, 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 Fotivda.
Exclusivity Information
Fotivda holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Fotivda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2026 |
US patents provide insights into the exclusivity only within the United States, but Fotivda 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 Fotivda's family patents as well as insights into ongoing legal events on those patents.
Fotivda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fotivda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 05, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fotivda Generics:
There are no approved generic versions for Fotivda as of now.
About Fotivda
Fotivda is a drug owned by Aveo Pharmaceuticals Inc. It is used for treating advanced renal cell carcinoma by inhibiting angiogenesis with a vascular endothelial growth factor inhibitor in adults with certain treatment histories. Fotivda uses Tivozanib Hydrochloride as an active ingredient. Fotivda was launched by Aveo Pharms in 2021.
Approval Date:
Fotivda was approved by FDA for market use on 10 March, 2021.
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 Fotivda is 10 March, 2021, its NCE-1 date is estimated to be 10 March, 2025.
Active Ingredient:
Fotivda uses Tivozanib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tivozanib Hydrochloride ingredient
Treatment:
Fotivda is used for treating advanced renal cell carcinoma by inhibiting angiogenesis with a vascular endothelial growth factor inhibitor in adults with certain treatment histories.
Dosage:
Fotivda is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.89MG BASE | CAPSULE | Prescription | ORAL |
| EQ 1.34MG BASE | CAPSULE | Prescription | ORAL |