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sustol Drug Patent Profile

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When do Sustol patents expire, and what generic alternatives are available?

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

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	4,317
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for sustol
What excipients (inactive ingredients) are in sustol?	sustol excipients list
DailyMed Link:	sustol at DailyMed

Drug patent expirations by year for sustol

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sustol

Generic Entry Date for sustol^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 022445 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.

Recent Clinical Trials for sustol

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Heron Therapeutics	Phase 4

See all sustol clinical trials

Pharmacology for sustol

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for sustol

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR PREVENTION OF NAUSEA AND VOMITING

Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heron Theraps Inc	SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Heron Theraps Inc	SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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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	⤷ Try a Trial	⤷ Try a Trial
Heron Theraps Inc	SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for sustol

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296 Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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: ⤷ Try a Trial

Canada

Patent: 79297
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1052376
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 96629
Estimated Expiration: ⤷ Try a Trial

Patent: 02012
Estimated Expiration: ⤷ Try a Trial

Patent: 24492
Estimated Expiration: ⤷ Try a Trial

Patent: 34817
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 13477
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 57972
Estimated Expiration: ⤷ Try a Trial

Patent: 08514646
Estimated Expiration: ⤷ Try a Trial

Patent: 12107064
Estimated Expiration: ⤷ Try a Trial

Patent: 15034182
Estimated Expiration: ⤷ Try a Trial

Patent: 17008113
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 070083851
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 29574
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 07966
Estimated Expiration: ⤷ Try a Trial

Patent: 0616650
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2012107064	SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITION	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006037116		⤷ Try a Trial
Taiwan	I407966		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration