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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 Cumberland 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

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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:	4,591
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

Drug patent expirations by year for SANCUSO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SANCUSO

Generic Entry Date for SANCUSO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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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.

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Country	Patent Number	Title	Estimated Expiration
China	1747724	Transdermal granisetron	⤷ Sign Up
Ukraine	83362	ПЛАСТЫРЬ, СОДЕРЖАЩИЙ ГРАНИЗЕТРОН, ПРИМЕНЕНИЕ ГРАНИЗЕТРОНА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ;ПЛАСТИР, ЩО МІСТИТЬ ГРАНІЗЕТРОН, ЗАСТОСУВАННЯ ГРАНІЗЕТРОНУ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ (PLASTER, CONTAINING GRANISETRON, USE OF GRANISETRON (VARIANTS) AND METHOD FOR TREATMENT)	⤷ Sign Up
Poland	218351		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004069141		⤷ Sign Up
Japan	4146486		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration