SANCUSO Drug Patent Profile

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

See drug prices for SANCUSO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for SANCUSO

NDA:

022198

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

See all SANCUSO clinical trials

Pharmacology for SANCUSO

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SANCUSO

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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.

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

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			Y

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

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

Austria

Brazil

Canada

China

Costa Rica

Croatia

Denmark

Ecuador

European Patent Office

Georgia, Republic of

Germany

Hong Kong

Iceland

Israel

Japan

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

United Kingdom

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
Mexico	PA05008343	GRANISETRON TRANSDERMICO. (TRANSDERMAL GRANISETRON.)
Poland	379027	Przezskórny granisetron (TRANSDERMAL GRANISETRON)
Costa Rica	7923	GRANISETRON TRANSDERMICO