SANCUSO Drug Patent Profile
✉ Email this page to a colleague
When do Sancuso patents expire, and what generic alternatives are available?
Sancuso is a drug marketed by Kyowa Kirin and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty patent family members in thirty-one countries.
The generic ingredient in SANCUSO 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 Sancuso
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 22, 2025. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SANCUSO
International Patents: | 40 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 20 |
Patent Applications: | 4,840 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SANCUSO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SANCUSO |
What excipients (inactive ingredients) are in SANCUSO? | SANCUSO excipients list |
DailyMed Link: | SANCUSO at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SANCUSO
Generic Entry Date for SANCUSO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FILM, EXTENDED RELEASE;TRANSDERMAL |
*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 SANCUSO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Solasia Pharma K.K. | Phase 1 |
Kyowa Kirin, Inc. | Phase 1 |
PPD | Phase 1 |
Pharmacology for SANCUSO
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SANCUSO
Paragraph IV (Patent) Challenges for SANCUSO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SANCUSO | Transdermal System | granisetron | 3.1 mg/24 hrs | 022198 | 1 | 2015-10-09 |
US Patents and Regulatory Information for SANCUSO
SANCUSO is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SANCUSO 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 SANCUSO
Transdermal granisetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kyowa Kirin | SANCUSO | granisetron | FILM, EXTENDED RELEASE;TRANSDERMAL | 022198-001 | Sep 12, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
EU/EMA Drug Approvals for SANCUSO
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 SANCUSO
See the table below for patents covering SANCUSO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2515094 | GRANISETRON TRANSDERMIQUE (TRANSDERMAL GRANISETRON) | ⤷ Try a Trial |
Serbia | 20050600 | TRANSDERMALNI GRANISETRON (TRANSDERMAL GRANISETRON) | ⤷ Try a Trial |
Slovenia | 1589956 | ⤷ Try a Trial | |
European Patent Office | 1589956 | GRANISETRON TRANSDERMIQUE (TRANSDERMAL GRANISETRON) | ⤷ Try a Trial |
Serbia | 51696 | TRANSDERMALNI GRANISETRON (TRANSDERMAL GRANISETRON) | ⤷ Try a Trial |
Costa Rica | 7923 | GRANISETRON TRANSDERMICO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |