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Last Updated: July 14, 2025

LONSURF Drug Patent Profile


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When do Lonsurf patents expire, and when can generic versions of Lonsurf launch?

Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in thirty-three countries.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.

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Drug patent expirations by year for LONSURF
Drug Prices for LONSURF

See drug prices for LONSURF

Recent Clinical Trials for LONSURF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yonsei UniversityPhase 1/Phase 2
TaihoPhase 2
AmgenPhase 3

See all LONSURF clinical trials

Paragraph IV (Patent) Challenges for LONSURF
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LONSURF Tablets tipiracil hydrochloride; trifluridine 15 mg/6.14 mg and 20 mg/8.19 mg 207981 4 2019-09-23

US Patents and Regulatory Information for LONSURF

LONSURF is protected by ten US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No RE46284 ⤷  Try for Free ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No 10,456,399 ⤷  Try for Free ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes RE46284 ⤷  Try for Free ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes 10,457,666 ⤷  Try for Free Y Y ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No 9,943,537 ⤷  Try for Free ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes 9,943,537 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LONSURF

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 5,744,475 ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 5,744,475 ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 6,479,500 ⤷  Try for Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 6,479,500 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LONSURF

When does loss-of-exclusivity occur for LONSURF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14282281
Patent: Stabilized crystal of tipiracil hydrochloride, and crystallization method for same
Estimated Expiration: ⤷  Try for Free

Patent: 17208215
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Try for Free

Patent: 18219967
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2015031619
Patent: forma cristalina estável de cloridrato de tipiracil e método de cristalização para a mesma
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 14999
Patent: CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Try for Free

Patent: 85006
Patent: CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Try for Free

China

Patent: 4395307
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME
Estimated Expiration: ⤷  Try for Free

Patent: 6967051
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (Stable crystal form of tipiracil hydrochloride and crystallization method for the same)
Estimated Expiration: ⤷  Try for Free

Patent: 9912573
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Try for Free

Patent: 0746403
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0211903
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 24868
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 12255
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 12255
Patent: CRISTAL STABILISÉ DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCÉDÉ DE CRISTALLISATION (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Try for Free

Patent: 05779
Patent: FORME CRISTALLINE STABLE DE CHLORHYDRATE DE TIPIRACIL ET SON PROCÉDÉ DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Try for Free

Georgia, Republic of

Patent: 0186841
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME
Estimated Expiration: ⤷  Try for Free

Patent: 0186875
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLI- ZATION METHOD FOR SAME
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 03071
Patent: 地匹福林鹽酸鹽的穩定型晶體及其結晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 57352
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 2014203877
Patent: チピラシル塩酸塩の安定形結晶及びその結晶化方法
Estimated Expiration: ⤷  Try for Free

Patent: 64409
Estimated Expiration: ⤷  Try for Free

Patent: 26883
Estimated Expiration: ⤷  Try for Free

Patent: 18145204
Patent: チピラシル塩酸塩の安定形結晶及びその結晶化方法 (STABLE FORM CRYSTAL OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD THEREFOR)
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 12255
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 3410
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 15016986
Patent: FORMA DE CRISTAL ESTABLE DE CLORHIDRATO DE TIPIRACIL, Y METODO DE CRISTALIZACION DEL MISMO. (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME.)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 668
Patent: Cristal stabilisé de chlorhydrate de tipiracil, et son procédé de cristallisation
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 4090
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 015502809
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 12255
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 12255
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 40417
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TYPIRACYL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)
Estimated Expiration: ⤷  Try for Free

Patent: 74441
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TIPIRACIL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)
Estimated Expiration: ⤷  Try for Free

Patent: 16100972
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 691
Patent: STABILNI KRISTALNI OBLIK TIPIRACIL HIDROHLORIDA I POSTUPAK KRISTALIZACIJE ISTOG (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 201710916Y
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Patent: 201912293U
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Patent: 202007643S
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Patent: 201509189S
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 12255
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1806346
Estimated Expiration: ⤷  Try for Free

Patent: 160020560
Patent: 티피라실 염산염의 안정형 결정 및 그 결정화 방법 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 98408
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 39592
Estimated Expiration: ⤷  Try for Free

Patent: 1534601
Patent: Stabilized crystal of tipiracil hydrochloride, and crystallization method for same
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 2626
Patent: СТАБІЛЬНА КРИСТАЛІЧНА ФОРМА ТИПІРАЦИЛУ ГІДРОХЛОРИДУ І СПОСІБ ЇЇ КРИСТАЛІЗАЦІЇ
Estimated Expiration: ⤷  Try for Free

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 LONSURF around the world.

Country Patent Number Title Estimated Expiration
Lithuania C1849470 ⤷  Try for Free
Russian Federation 2016100972 СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ ⤷  Try for Free
Luxembourg C00036 ⤷  Try for Free
South Korea 20070104559 ANTICANCER DRUG CONTAINING alpha;,alpha;,alpha;-TRIFLUOROTHYMIDINE AND THYMIDINE PHOSPHORYLASE INHIBITOR ⤷  Try for Free
Japan WO2017135412 重度腎機能障害を有する癌患者に対する治療方法 ⤷  Try for Free
Ukraine 112626 СТАБІЛЬНА КРИСТАЛІЧНА ФОРМА ТИПІРАЦИЛУ ГІДРОХЛОРИДУ І СПОСІБ ЇЇ КРИСТАЛІЗАЦІЇ ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LONSURF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 1790063-0 Sweden ⤷  Try for Free PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 CA 2017 00036 Denmark ⤷  Try for Free PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands ⤷  Try for Free PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 322 20-2017 Slovakia ⤷  Try for Free PRODUCT NAME: TRIFLURIDIN/TIPIRACIL VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 LUC00036 Luxembourg ⤷  Try for Free PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 17C1028 France ⤷  Try for Free PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Lonsurf

Last updated: July 3, 2025

Introduction to Lonsurf

Lonsurf, a combination of trifluridine and tipiracil, stands out as a critical treatment for patients with metastatic colorectal cancer and certain gastric cancers. First approved by the U.S. Food and Drug Administration (FDA) in 2015, this oral chemotherapy agent inhibits cancer cell growth by disrupting DNA synthesis. Taiho Pharmaceutical, in partnership with Servier, drives its development and commercialization, targeting markets where advanced oncology therapies command premium pricing. As demand for personalized cancer treatments rises, Lonsurf exemplifies how targeted drugs navigate complex regulatory pathways to reach global patients.

Current Market Dynamics

The oncology market surges amid rising cancer incidences, with Lonsurf carving a niche in the colorectal cancer segment. Global colorectal cancer cases topped 1.9 million in 2020, according to the World Health Organization, fueling demand for late-line therapies like Lonsurf. This drug primarily serves patients who have exhausted standard treatments, positioning it in a high-value market estimated at $20 billion annually by IQVIA data.

Market growth for Lonsurf hinges on expanding indications and geographic reach. In 2023, sales expanded in Europe and Asia-Pacific regions, driven by Servier's distribution efforts. However, supply chain disruptions and pricing pressures in emerging markets temper this momentum. Competitors such as Bristol Myers Squibb's Opdivo and Merck's Keytruda erode market share by offering immunotherapy alternatives, yet Lonsurf maintains an edge through its proven efficacy in refractory cases. Analysts note that Lonsurf's market penetration correlates with healthcare spending; for instance, U.S. adoption outpaces that in cost-sensitive regions like Latin America.

Competitive Landscape

Lonsurf faces stiff competition in the metastatic colorectal cancer space, where innovation accelerates. Key rivals include Regeneron and Sanofi's Zaltrap and Amgen's Vectibix, both targeting similar patient populations. Unlike these biologics, Lonsurf's small-molecule formulation offers oral administration convenience, appealing to patients fatigued by infusion therapies. Market data from Evaluate Pharma indicates Lonsurf captured approximately 5% of the global metastatic colorectal cancer market in 2022, with projections for 7% growth by 2027 as clinical trials expand its use.

Strategic alliances bolster Lonsurf's position. Taiho's collaboration with Servier extends to over 70 countries, enabling rapid market entry and localized pricing strategies. Yet, biosimilar threats loom as patents expire; for example, generic entrants could disrupt pricing post-2029, based on current intellectual property timelines. This dynamic forces Taiho to innovate, with ongoing trials exploring Lonsurf combinations with immunotherapies to differentiate it further.

Regulatory and Patent Landscape

Regulatory approvals shape Lonsurf's trajectory, with the FDA and European Medicines Agency (EMA) granting it orphan drug status for gastric cancer in 2019. This designation accelerates review processes and provides market exclusivity, shielding Lonsurf from generics until patent cliffs. Taiho holds core patents on trifluridine/tipiracil formulations until 2028 in major markets, as per USPTO records, but extensions via pediatric exclusivity could push this to 2030.

Globally, varying regulations impact accessibility. In China, the National Medical Products Administration approved Lonsurf in 2021, opening a market of over 400,000 annual colorectal cancer cases. However, stringent pricing negotiations under China's National Reimbursement Drug List delay widespread adoption. These factors underscore the need for adaptive strategies, as regulatory hurdles in developing regions could limit Lonsurf's financial upside despite its clinical benefits.

Financial Performance and Trajectory

Lonsurf's financial story reflects broader pharmaceutical trends, with revenues climbing from $500 million in 2020 to over $800 million in 2023, per Taiho's financial filings. This growth stems from expanded indications and robust U.S. sales, where it generates nearly 60% of total revenue. Net profits, however, fluctuate due to high R&D costs; Taiho reported a 15% operating margin in 2023, bolstered by cost efficiencies in manufacturing.

Forecasts from Bloomberg Intelligence project Lonsurf revenues to reach $1.2 billion by 2026, driven by market expansion in Asia and potential label extensions. Yet, patent expirations pose risks; analysts estimate a 20-30% revenue drop post-2029 without new protections. Taiho counters this by investing in pipeline drugs, allocating 25% of 2023 profits to R&D. Investor sentiment remains positive, with Taiho's stock rising 18% year-to-date on Lonsurf's performance, though macroeconomic factors like inflation could squeeze margins.

Future Outlook

Looking ahead, Lonsurf's market dynamics will pivot on clinical trial outcomes and global health policies. Phase III trials combining Lonsurf with pembrolizumab could double its addressable market by 2025, targeting earlier-stage patients. Financially, Taiho aims for sustained growth through acquisitions, potentially acquiring complementary assets to offset Lonsurf's lifecycle risks. However, geopolitical tensions and currency fluctuations in key markets like Japan and the EU may introduce volatility.

Experts predict a compound annual growth rate of 12% for Lonsurf through 2030, per Statista projections, assuming successful navigation of patent challenges. This trajectory positions Lonsurf as a bellwether for oral oncology drugs, where innovation meets fiscal discipline in an era of rising healthcare costs.

Key Takeaways

  • Lonsurf drives significant revenue for Taiho, with 2023 sales exceeding $800 million, but faces threats from patent expirations around 2029.
  • The drug maintains a competitive edge in metastatic colorectal cancer through its oral format and expanding indications, capturing about 5% of the global market.
  • Regulatory approvals and partnerships enhance accessibility, yet pricing pressures in emerging markets could limit growth.
  • Financial projections forecast revenues up to $1.2 billion by 2026, contingent on trial successes and market expansions.
  • Investors should monitor R&D investments and competitive entries to gauge long-term sustainability.

FAQs

1. What is Lonsurf primarily used for?
Lonsurf treats metastatic colorectal cancer and certain gastric cancers in patients who have failed prior therapies, offering an oral alternative to traditional infusions.

2. How does Lonsurf's patent status affect its market?
Core patents expire around 2028-2030, potentially allowing generics to enter and reduce prices, which could erode Taiho's market share without new innovations.

3. What factors drive Lonsurf's revenue growth?
Revenue growth stems from expanded geographic sales, new indications from clinical trials, and strategic partnerships, with U.S. markets contributing the majority.

4. Who are Lonsurf's main competitors?
Key competitors include Opdivo from Bristol Myers Squibb and Keytruda from Merck, which offer immunotherapy options for similar cancer indications.

5. What risks could impact Lonsurf's financial trajectory?
Patent cliffs, regulatory delays in key regions, and competition from biosimilars pose significant risks, potentially leading to revenue declines post-2029.

Sources

  1. Taiho Pharmaceutical. Annual Financial Report 2023. Available at: Taiho investor relations portal.
  2. IQVIA Institute. Global Oncology Trends 2023 Report. Available at: IQVIA publications.
  3. Evaluate Pharma. World Preview 2024, Outlook to 2030. Available at: Evaluate Pharma database.
  4. United States Patent and Trademark Office (USPTO). Patent details for trifluridine/tipiracil formulations. Available at: USPTO search.
  5. Statista. Pharmaceutical Market Insights Report 2023. Available at: Statista platform.
  6. Bloomberg Intelligence. Oncology Sector Analysis, February 2024. Available at: Bloomberg terminal access.

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