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: | 51 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,182 |
| 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 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 |
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 ⤷ 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
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
| 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 | ||||
| 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
| 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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101052376 | Semi-solid delivery vehicle and pharmaceutical compositions | ⤷ Try a Trial |
| European Patent Office | 1796629 | VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
| Japan | 2015034182 | 半固体送達賦形剤および薬学的組成物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
| Japan | 2008514646 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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.
ISSN: 2162-2639
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