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Last Updated: June 27, 2022

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

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Drug patent expirations by year for SANCUSO
Drug Prices for SANCUSO

See drug prices for SANCUSO

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
Solasia Pharma K.K.Phase 1
Kyowa Kirin, Inc.Phase 1
PPDPhase 1

See all SANCUSO clinical trials

Pharmacology 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

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Dow
Boehringer Ingelheim
Mallinckrodt
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.