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SUSTOL Drug 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 seven patents protecting this drug.
This drug has seventeen 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.
US ANDA Litigation and 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: | 17 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 34 |
| Patent Applications: | 2,268 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUSTOL |
| DailyMed Link: | SUSTOL at DailyMed |
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 |
US Patents and Regulatory Information for SUSTOL
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Heron Theraps Inc | SUSTOL | granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SUSTOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2529574 | Start Trial |
| European Patent Office | 2902012 | Start Trial |
| Hong Kong | 1213477 | Start Trial |
| Taiwan | 200616650 | Start Trial |
| Japan | 2015034182 | Start Trial |
| Japan | 2012107064 | Start Trial |
| Japan | 2008514646 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
