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
Summary for SUSTOL
| International Patents: | 18 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Patent Applications: | 4,930 |
| 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 |
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
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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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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.
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