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Last Updated: May 20, 2022

SUSTOL Drug Patent Profile


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When do Sustol patents expire, and when can generic versions of Sustol launch?

Sustol is a drug marketed by Heron Theraps Inc and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

The generic ingredient in SUSTOL is granisetron. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the granisetron profile page.

DrugPatentWatch® Generic Entry Outlook for Sustol

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SUSTOL
Drug patent expirations by year for SUSTOL
Drug Prices for SUSTOL

See drug prices for SUSTOL

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SUSTOL
Generic Entry Date for SUSTOL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTION, EXTENDED RELEASE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SUSTOL

US Patents and Regulatory Information for SUSTOL

SUSTOL is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUSTOL is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SUSTOL

Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLACTIC TREATMENT OF NAUSEA AND VOMITING, INCLUDING PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED CHEMOTHERAPY

Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OR PREVENTION OF NAUSEA AND VOMITING

Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLACTIC TREATMENT OF NAUSEA AND VOMITING, INCLUDING PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED CHEMOTHERAPY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SUSTOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 See Plans and Pricing See Plans and Pricing
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SUSTOL

When does loss-of-exclusivity occur for SUSTOL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05289425
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79297
Estimated Expiration: See Plans and Pricing

China

Patent: 1052376
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96629
Estimated Expiration: See Plans and Pricing

Patent: 02012
Estimated Expiration: See Plans and Pricing

Patent: 24492
Estimated Expiration: See Plans and Pricing

Patent: 34817
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 13477
Estimated Expiration: See Plans and Pricing

Japan

Patent: 57972
Estimated Expiration: See Plans and Pricing

Patent: 08514646
Estimated Expiration: See Plans and Pricing

Patent: 12107064
Estimated Expiration: See Plans and Pricing

Patent: 15034182
Estimated Expiration: See Plans and Pricing

Patent: 17008113
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 070083851
Estimated Expiration: See Plans and Pricing

Spain

Patent: 29574
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 07966
Estimated Expiration: See Plans and Pricing

Patent: 0616650
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SUSTOL around the world.

Country Patent Number Title Estimated Expiration
Taiwan I407966 See Plans and Pricing
Spain 2529574 See Plans and Pricing
Hong Kong 1213477 半固體遞送載體和藥物組合物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
Taiwan 200616650 Semi-solid delivery vehicle and pharmaceutical compositions See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.