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 these, 5 drug patents are active and 2 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6790458 Pharmaceutical compositions using semi-solid delivery vehicle
May, 2021

(3 years ago)

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

(3 years ago)

Expired
US8252305 Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Sep, 2024

(2 months from now)

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

(2 months from now)

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

(2 months from now)

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

(2 months from now)

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

(2 months from now)

Active


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.





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.

Market Authorisation 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 injection, extended release form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG/0.4ML (10MG/0.4ML) INJECTION, EXTENDED RELEASE Prescription SUBCUTANEOUS