SANCUSO Drug Patent Profile
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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: | 43 |
Clinical Trials: | 20 |
Patent Applications: | 4,930 |
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 Generic Entry Opportunity 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 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 SANCUSO
Transdermal granisetron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | 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 |
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
When does loss-of-exclusivity occur for SANCUSO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 04210181
Estimated Expiration: See Plans and Pricing
Austria
Patent: 8454
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0407280
Estimated Expiration: See Plans and Pricing
Canada
Patent: 15094
Estimated Expiration: See Plans and Pricing
China
Patent: 47724
Estimated Expiration: See Plans and Pricing
Patent: 2416009
Estimated Expiration: See Plans and Pricing
Patent: 2526043
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 23
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0050695
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 89956
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 055953
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 89956
Estimated Expiration: See Plans and Pricing
Georgia, Republic of
Patent: 0084390
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2004007888
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 82199
Estimated Expiration: See Plans and Pricing
Iceland
Patent: 97
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9881
Estimated Expiration: See Plans and Pricing
Japan
Patent: 46486
Estimated Expiration: See Plans and Pricing
Patent: 06516601
Estimated Expiration: See Plans and Pricing
Patent: 08195738
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05008343
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 616
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 1103
Estimated Expiration: See Plans and Pricing
Norway
Patent: 1441
Estimated Expiration: See Plans and Pricing
Patent: 053663
Estimated Expiration: See Plans and Pricing
Poland
Patent: 8351
Estimated Expiration: See Plans and Pricing
Patent: 9027
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 89956
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 55387
Estimated Expiration: See Plans and Pricing
Patent: 05127599
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 696
Estimated Expiration: See Plans and Pricing
Patent: 050600
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 89956
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0506128
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 0893158
Estimated Expiration: See Plans and Pricing
Patent: 050116365
Estimated Expiration: See Plans and Pricing
Spain
Patent: 87695
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 362
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 02662
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 SANCUSO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2004210181 | Transdermal granisetron | See Plans and Pricing |
Mexico | PA05008343 | GRANISETRON TRANSDERMICO. (TRANSDERMAL GRANISETRON.) | See Plans and Pricing |
Poland | 379027 | Przezskórny granisetron (TRANSDERMAL GRANISETRON) | See Plans and Pricing |
Costa Rica | 7923 | GRANISETRON TRANSDERMICO | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |