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Last Updated: May 13, 2021

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SANCUSO Drug 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

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Drug patent expirations by year for SANCUSO
Drug Prices for SANCUSO

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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

SponsorPhase
Fudan UniversityPhase 2
Radboud UniversityPhase 4
Milton S. Hershey Medical CenterPhase 2

See all SANCUSO clinical trials

Pharmacology for SANCUSO
Paragraph IV (Patent) Challenges for SANCUSO
Tradename Dosage Ingredient NDA Submissiondate
SANCUSO FILM, EXTENDED RELEASE;TRANSDERMAL granisetron 022198 2015-10-09

US Patents and Regulatory Information for 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   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Dow
Boehringer Ingelheim
Mallinckrodt
AstraZeneca

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