{"schema_version":"1.0","type":"article","title":"泰合上市兩週翻倍，美國時鐘卻握在法院手上","url":"https://drugnews.com.tw/articles/2026-11-05-taho-beqia-eliquis-patent-suit-30-month-clock.html","markdown_url":"https://drugnews.com.tw/articles/2026-11-05-taho-beqia-eliquis-patent-suit-30-month-clock.md","lang":"zh-Hant","date":"2026-11-05","publish_at":"2026-11-05T08:00:00+08:00","updated_at":"2026-11-05","category":"商業分析系列","topic":"商業分析系列","tags":["泰合","BEQIA","Eliquis","505(b)(2)","專利訴訟"],"summary":"泰合（6467）2026年11月3日收246元，較承銷價105.6元漲133%，推升股價的是日本兒童新適應症申請。BMS與輝瑞在德拉瓦州對BEQIA提告，可能觸發最長30個月的FDA核准暫停；Eliquis的Medicare議價2026年已降56%，2028年4月起學名藥進場，BEQIA的美國價值取決於何時、以什麼價格進場。","key_points":["泰合（6467）2026年11月3日收盤246元，較2026年10月20日承銷價105.6元上漲133%。","BMS與輝瑞2026年10月在德拉瓦州聯邦地院控告泰合BEQIA專利侵權；依Hatch-Waxman制度，FDA最終核准最長可暫停30個月，約至2029年春天。","Eliquis 30天藥量Medicare議定價231美元，比2023年標價521美元低56%，2026年1月1日生效；和解學名藥2028年4月1日起可進場。"],"facts":[{"claim":"泰合（6467）2026年11月3日收盤246元。","value":null,"unit":"","as_of":"2026-11-03","source":"https://www.twse.com.tw/rwd/zh/afterTrading/MI_INDEX?date=20261103&type=ALLBUT0999&response=json"},{"claim":"泰合2026年10月20日以每股105.6元承銷價上市。","value":null,"unit":"","as_of":"2026-10-20","source":"https://money.udn.com/money/story/5607/9827028"},{"claim":"泰合上市前競價拍賣加權平均得標價為177.88元。","value":null,"unit":"","as_of":"2026-10-16","source":"https://drugnews.com.tw/filings/6467.html"},{"claim":"Miyarisan於2026年10月30日就TAH4411兒童急性腸胃炎嘔吐適應症在日本提出新藥上市申請。","value":null,"unit":"","as_of":"2026-10-30","source":"https://drugnews.com.tw/filings/6467.html"},{"claim":"BMS與輝瑞在美國德拉瓦州聯邦地院對泰合BEQIA提出專利侵權訴訟，案號1:26-cv-01374。","value":null,"unit":"","as_of":"2026-10-29","source":"https://drugnews.com.tw/filings/6467.html"},{"claim":"泰合於美國時間2026年10月23日收到BEQIA專利訴訟通知。","value":null,"unit":"","as_of":"2026-10-27","source":"https://uanalyze.com.tw/articles/3641057737"},{"claim":"BEQIA美國NDA審查目標日為2027年4月22日。","value":null,"unit":"","as_of":"2026-09-07","source":"https://www.tahopharma.com/news-detail/132/"},{"claim":"BMS 2025年Eliquis全球營收144億美元、年增8%，美國營收102億美元。","value":null,"unit":"","as_of":"2026-02-05","source":"https://www.sec.gov/Archives/edgar/data/14272/000001427226000002/a2025q4ex991.htm"},{"claim":"FDA 2016年最終規則確認30個月核准暫停適用505(b)(2)申請。","value":null,"unit":"","as_of":"2016-10-06","source":"https://www.govinfo.gov/content/pkg/FR-2016-10-06/html/2016-22690.htm"},{"claim":"2020年8月德拉瓦地院判決Eliquis化合物專利與配方專利有效。","value":null,"unit":"","as_of":"2020-08-05","source":"https://www.biopharmadive.com/news/bristol-myers-pfizer-eliquis-patent-court-ruling/583027/"},{"claim":"未和解的Sigmapharm、Sunshine Lake與Unichem被判須等到2031年才能上市Eliquis學名藥。","value":null,"unit":"","as_of":"2020-08-05","source":"https://www.biopharmadive.com/news/bristol-myers-pfizer-eliquis-patent-court-ruling/583027/"},{"claim":"2021年9月3日美國聯邦巡迴上訴法院維持Eliquis專利有效的判決。","value":null,"unit":"","as_of":"2021-09-03","source":"https://www.cafc.uscourts.gov/opinions-orders/20-2229.opinion.9-3-2021_1829263.pdf"},{"claim":"和解的apixaban學名藥最早可於2028年4月1日在美國上市。","value":null,"unit":"","as_of":"2021-09-03","source":"https://news.bms.com/news/details/2021/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-decision-by-the-U.S.-Court-of-Appeals-for-the-Federal-Circuit-upholding-the-Eliquis-Patents/default.aspx"},{"claim":"Eliquis 30天藥量Medicare議定價231美元，較2023年標價521美元低56%，2026年1月1日生效。","value":null,"unit":"","as_of":"2024-08-15","source":"https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026"},{"claim":"FDA 2019年分析：4家學名藥競爭時平均出廠價比原廠低約79%，6家以上降幅超過95%。","value":null,"unit":"","as_of":"2019-12-01","source":"https://www.fda.gov/media/133509/download"}],"sections":["01｜兩根漲停，買的是日本的權利金","02｜一張口溶膜，為什麼讓輝瑞和 BMS 出手","03｜上一批挑戰者，最後換到的是一個日期","04｜30 個月：FDA 目標日之後的第二個時鐘","05｜價格這把尺，2026 年已經先被砍一刀","06｜台灣藥廠打過這場仗，結局多半是一個約定日期","07｜兩個時鐘，一張股價","參考資料"],"references":[{"title":"泰合公告日本授權夥伴 Miyarisan 就 TAH4411 兒童新適應症提出新藥上市申請","source":"公開資訊觀測站重大訊息（6467","date":"2026-10-30","url":"https://drugnews.com.tw/filings/6467.html"},{"title":"泰合更正公告 BEQIA（TAH3311）美國專利訴訟案相關文書案號","source":"公開資訊觀測站重大訊息（6467","date":"2026-10-29","url":"https://drugnews.com.tw/filings/6467.html"},{"title":"泰合公告初次上市前現金增資收足股款（競價加權平均得標價 177.88 元","source":"公開資訊觀測站重大訊息（6467","date":"2026-10-16","url":"https://drugnews.com.tw/filings/6467.html"},{"title":"泰合生技抗血栓口溶膜美國 NDA 審查完成目標日期","source":"泰合生技官網","date":"2026-09-07","url":"https://www.tahopharma.com/news-detail/132/"},{"title":"泰合上市首日股漲 89%","source":"經濟日報","date":"2026-10-20","url":"https://money.udn.com/money/story/5607/9827028"},{"title":"泰合抗血栓口溶膜遭美藥廠提出專利訴訟 續推進產品上市進展與全球商業化","source":"優分析（轉載鉅亨網","date":"2026-10-27","url":"https://uanalyze.com.tw/articles/3641057737"},{"title":"〈焦點股〉泰合上演蜜月行情漲逾1倍","source":"優分析（轉載鉅亨網","date":"2026-10-20","url":"https://uanalyze.com.tw/articles/6979657412"},{"title":"製藥公協會推動學名藥縮短上市時程","source":"經濟日報","date":"2026-10-26","url":"https://money.udn.com/money/story/5607/9838113"},{"title":"Bristol Myers Squibb Reports Fourth Quarter and Full-Year 2025 Financial Results","source":"U.S. SEC Form 8-K Exhibit 99.1","date":"2026-02-05","url":"https://www.sec.gov/Archives/edgar/data/14272/000001427226000002/a2025q4ex991.htm"},{"title":"The Bristol-Myers Squibb-Pfizer Alliance is pleased with the U.S. District Court decision to uphold both the composition of matter patent and formulation patent covering Eliquis","source":"BMS 新聞稿","date":"2020-08-05","url":"https://news.bms.com/news/details/2020/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-U.S.-District-Court-decision-to-uphold-both-the-composition-of-matter-COM-patent-US-6967208-and-formulation-patent-US-9326945-covering-Eliquis/default.aspx"},{"title":"The Bristol Myers Squibb-Pfizer Alliance is pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis Patents","source":"BMS 新聞稿","date":"2021-09-03","url":"https://news.bms.com/news/details/2021/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-decision-by-the-U.S.-Court-of-Appeals-for-the-Federal-Circuit-upholding-the-Eliquis-Patents/default.aspx"},{"title":"Bristol-Myers Squibb Co. v. Sigmapharm Laboratories, LLC, No. 2020-2229","source":"美國聯邦巡迴上訴法院","date":"2021-09-03","url":"https://www.cafc.uscourts.gov/opinions-orders/20-2229.opinion.9-3-2021_1829263.pdf"},{"title":"Abbreviated New Drug Applications and 505(b)(2) Applications, Final Rule","source":"Federal Register Vol. 81 No. 194","date":"2016-10-06","url":"https://www.govinfo.gov/content/pkg/FR-2016-10-06/html/2016-22690.htm"},{"title":"Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026","source":"CMS","date":"2024-08-15","url":"https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026"},{"title":"Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices","source":"FDA","date":"2019-12-01","url":"https://www.fda.gov/media/133509/download"},{"title":"Bristol Myers, Pfizer win Eliquis patent case, delaying generics","source":"BioPharma Dive","date":"2020-08-05","url":"https://www.biopharmadive.com/news/bristol-myers-pfizer-eliquis-patent-court-ruling/583027/"},{"title":"臺灣證券交易所每日收盤行情與個股日成交資訊（6467，2026-10-20 至 11-03","source":"臺灣證券交易所","date":"2026-11-03","url":"https://www.twse.com.tw/rwd/zh/afterTrading/MI_INDEX?date=20261103&type=ALLBUT0999&response=json"}],"images":[{"alt":"泰合股價的三把尺：承銷價 105.6 元、競價得標均價 177.88 元、11 月 3 日收盤 246 元","url":"https://drugnews.com.tw/assets/articles/taho-beqia-eliquis-patent-suit-30-month-clock/fig4_price_anchor.png"},{"alt":"Apixaban 打在凝血瀑布的哪一環，BEQIA 換的是給藥方式","url":"https://drugnews.com.tw/assets/articles/taho-beqia-eliquis-patent-suit-30-month-clock/fig1_mechanism.png"},{"alt":"BEQIA 的兩個時鐘：FDA 審查和專利清障，兩道門都過了才能在美國上市","url":"https://drugnews.com.tw/assets/articles/taho-beqia-eliquis-patent-suit-30-month-clock/fig2_timeline.png"},{"alt":"2028 年前後，BEQIA 在美國要比的對手換了","url":"https://drugnews.com.tw/assets/articles/taho-beqia-eliquis-patent-suit-30-month-clock/fig3_price_frame.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/taho-beqia-eliquis-patent-suit-30-month-clock/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-11-05）。泰合上市兩週翻倍，美國時鐘卻握在法院手上。https://drugnews.com.tw/articles/2026-11-05-taho-beqia-eliquis-patent-suit-30-month-clock.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}