Votrient is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Votrient's patents have been open to challenges since 19 October, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 19, 2023. Details of Votrient'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). | |||
| US7105530 | Pyrimidineamines as angiogenesis modulators |
Oct, 2023
(1 year, 1 month ago) |
Expired
|
| US8114885 | Chemical compounds |
Dec, 2021
(2 years ago) |
Expired
|
| US7262203 | Pyrimidineamines as angiogenesis modulators |
Dec, 2021
(2 years ago) |
Expired
|
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 Votrient's patents.
Latest Legal Activities on Votrient's Patents
Given below is the list of recent legal activities going on the following patents of Votrient.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 18 Mar, 2024 | US8114885 |
| Maintenance Fee Reminder Mailed Critical | 02 Oct, 2023 | US8114885 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2019 | US8114885 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7262203 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Mar, 2018 | US7105530 |
| Email Notification Critical | 05 Jun, 2015 | US8114885 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Jun, 2015 | US8114885 |
| Correspondence Address Change Critical | 04 Jun, 2015 | US8114885 |
| Email Notification Critical | 04 Jun, 2015 | US7262203 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Jun, 2015 | US7262203 |
FDA has granted several exclusivities to Votrient. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Votrient, 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 Votrient.
Exclusivity Information
Votrient holds 4 exclusivities. All of its exclusivities have expired in 2019. Details of Votrient's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 19, 2014 |
| New Indication(I-649) | Apr 26, 2015 |
| Orphan Drug Exclusivity(ODE) | Apr 26, 2019 |
| Orphan Drug Exclusivity(ODE-23) | Apr 26, 2019 |
US patents provide insights into the exclusivity only within the United States, but Votrient 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 Votrient's family patents as well as insights into ongoing legal events on those patents.
Votrient's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Votrient's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 19, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Votrient Generic API suppliers:
Pazopanib Hydrochloride is the generic name for the brand Votrient. 4 different companies have already filed for the generic of Votrient, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Votrient's generic
About Votrient
Votrient is a drug owned by Novartis Pharmaceuticals Corp. Votrient uses Pazopanib Hydrochloride as an active ingredient. Votrient was launched by Novartis in 2009.
Approval Date:
Votrient was approved by FDA for market use on 19 October, 2009.
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 Votrient is 19 October, 2009, its NCE-1 date is estimated to be 19 October, 2013.
Active Ingredient:
Votrient uses Pazopanib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Pazopanib Hydrochloride ingredient
Dosage:
Votrient is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |
| EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |