Sustol is a drug owned by Heron Therapeutics Inc. It is protected by 7 US drug patents filed from 2016 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 28, 2024. Details of Sustol'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). | |||
| US8252305 | Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron |
Sep, 2024
(9 months ago) |
Expired
|
| US8252304 | Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron |
Sep, 2024
(9 months ago) |
Expired
|
| US9913910 | Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron |
Sep, 2024
(9 months ago) |
Expired
|
| US10357570 | Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron |
Sep, 2024
(9 months ago) |
Expired
|
| US8715710 | Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron |
Sep, 2024
(9 months ago) |
Expired
|
| US6613355 | Semi-solid delivery vehicle and pharmaceutical compositions |
Jun, 2021
(4 years ago) |
Expired
|
| US6790458 | Pharmaceutical compositions using semi-solid delivery vehicle |
May, 2021
(4 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 Sustol's patents.
Latest Legal Activities on Sustol's Patents
Given below is the list of recent legal activities going on the following patents of Sustol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 28 Feb, 2024 | US8252305 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 28 Feb, 2024 | US8252304 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 23 Jan, 2023 | US10357570 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Sep, 2021 | US9913910 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Feb, 2020 | US8252304 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Feb, 2020 | US8252305 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Jul, 2019 | US10357570 |
| Recordation of Patent Grant Mailed Critical | 23 Jul, 2019 | US10357570 |
| Email Notification Critical | 03 Jul, 2019 | US10357570 |
| Issue Notification Mailed Critical | 02 Jul, 2019 | US10357570 |
FDA has granted several exclusivities to Sustol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sustol, 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 Sustol.
Exclusivity Information
Sustol holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Sustol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 09, 2019 |
US patents provide insights into the exclusivity only within the United States, but Sustol 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 Sustol's family patents as well as insights into ongoing legal events on those patents.
Sustol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sustol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 28, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sustol Generics:
There are no approved generic versions for Sustol as of now.
Alternative Brands for Sustol
Sustol which is used for preventing and treating nausea and vomiting associated with chemotherapy and other conditions., has several other brand drugs using the same active ingredient (Granisetron). 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.
About Sustol
Sustol is a drug owned by Heron Therapeutics Inc. It is used for preventing and treating nausea and vomiting associated with chemotherapy and other conditions. Sustol uses Granisetron as an active ingredient. Sustol was launched by Heron Theraps Inc in 2016.
Approval Date:
Sustol was approved by FDA for market use on 09 August, 2016.
Active Ingredient:
Sustol uses Granisetron as the active ingredient. Check out other Drugs and Companies using Granisetron ingredient
Treatment:
Sustol is used for preventing and treating nausea and vomiting associated with chemotherapy and other conditions.
Dosage:
Sustol is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/0.4ML (10MG/0.4ML) | INJECTABLE | Prescription | SUBCUTANEOUS |