Sustol Patent Expiration

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

(2 months ago)

Expired
US8252304 Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Sep, 2024

(2 months ago)

Expired
US9913910 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Sep, 2024

(2 months ago)

Expired
US10357570 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Sep, 2024

(2 months ago)

Expired
US8715710 Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Sep, 2024

(2 months ago)

Expired
US6613355 Semi-solid delivery vehicle and pharmaceutical compositions
Jun, 2021

(3 years ago)

Expired
US6790458 Pharmaceutical compositions using semi-solid delivery vehicle
May, 2021

(3 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.

Given below is the list of recent legal activities going on the following patents of Sustol.

Activity Date Patent Number
Patent litigations
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 23 Jul, 2019 US10357570
Recordation of Patent Grant Mailed 23 Jul, 2019 US10357570
Email Notification 03 Jul, 2019 US10357570
Issue Notification Mailed 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

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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

Sustol has patent protection in a total of 10 countries. It has a significant patent presence in the US with 53.1% of its patents being US patents. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Sustol.

Family Patents

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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.

Drug Owner Drug Name
Cumberland
Sancuso
Roche
Kytril






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