SUSTOL Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SUSTOL?
- What are the global sales for SUSTOL?
- What is Average Wholesale Price for SUSTOL?
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 |
Drug Prices: | Drug price information for SUSTOL |
What excipients (inactive ingredients) are in SUSTOL? | SUSTOL excipients list |
DailyMed Link: | SUSTOL at DailyMed |
![SUSTOL drug patent expirations Drug patent expirations by year for SUSTOL](/p/graph/s/t/SUSTOL-patent-expirations.png)
![Drug Prices for SUSTOL](/p/graph/drug-price/SUSTOL.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for SUSTOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Heron Therapeutics | Phase 4 |
Pharmacology for SUSTOL
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OR PREVENTION OF NAUSEA AND VOMITING
Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SUSTOL
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
Patent: Semi-solid delivery vehicle and pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 79297
Patent: VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1052376
Patent: Semi-solid delivery vehicle and pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 96629
Patent: VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 02012
Patent: Véhicule d'administration semi-solide et compositions pharmaceutiques (Semi-solid delivery vehicle and pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up
Patent: 24492
Patent: VÉHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VECHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 34817
Patent: VÉHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 13477
Patent: 半固體遞送載體和藥物組合物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 57972
Estimated Expiration: ⤷ Sign Up
Patent: 08514646
Estimated Expiration: ⤷ Sign Up
Patent: 12107064
Patent: SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Patent: 15034182
Patent: 半固体送達賦形剤および薬学的組成物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 17008113
Patent: 半固体送達賦形剤および薬学的組成物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 070083851
Patent: SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 29574
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 07966
Estimated Expiration: ⤷ Sign Up
Patent: 0616650
Patent: Semi-solid delivery vehicle and pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
South Korea | 20070083851 | SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
European Patent Office | 1796629 | VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
Canada | 2579297 | VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
Japan | 2012107064 | SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |