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fda orange book 在台灣光鹽生物科技學苑 Facebook 八卦

2016-11-08 12:36:46 有 133 人按讚

<醫藥小專欄>什麼是橘皮書(The Orange Book)?
#FDA #ANDA #橘皮書 #專利連結 #資料專屬權

橘皮書(The Orange Book)是由美國食品藥物管理局FDA官方出版的書冊，正式名稱為「具治療等效性評估之核准藥品目錄(Approved Drug Products with Therapeutic Equivalences)」，登錄包含經FDA核准上市藥品之專利資訊，原係以「橘色封面」經年性公布，現可於網路上搜尋且定期更新。

#藥品資訊:商品名、活性成分、劑型、使用途徑、劑量等
#藥品上市許可資訊(核准申請碼、核准日期)與藥品藥證持有人
#藥品之專利資訊及其到期日
#藥品之資料專屬權資訊及其到期日
#電子查詢網址 http://www.accessdata.fda.gov/scripts/cder/ob/

美國各州為了控製藥物成本，幾乎都通過了鼓勵替代藥物產品(替代原廠藥)的法律和/或法規。因此要求FDA提供所有經批准的處方藥產品的安全性和有效性列表，以及除原開發廠之外的多源處方產品之治療等效性評估。

FDA在1970年代後期，為了回應美國各州政府的要求，開始著手清冊草案的整理，1979年在聯邦公報（44 FR 2932）公佈並廣蒐各界意見，1980年10月第一次出版的最終版本列入了適當的更正和增補。每個後續版本都包含新的核准藥物產品，並對數據進行了適當的補正。

1984 年通過之「藥價競爭與專利期間回復法」（Drug Price Competition and Patent Term Restoration Act of 1984, 亦稱 Hatch-Waxman Act ; 以下簡稱「藥價競爭法」）。原立法目的有二：即簡化學名藥上市申請程序(Abbreviated New Drug Application (ANDA)，加速學名藥上市時程，促使較便宜之學名藥早日進入市場嘉惠社會大眾；另一方面允許原開發藥廠在專利期間獲得資金回復，以便繼續促進藥品之研發及創新依據前述規定，FDA要求新藥申請人，應提供與其藥品有關之專利資訊予 FDA， FDA 將於核發新藥許可後，將此等專利資訊揭露於橘皮書中。

顧名思義，該清單包含FDA批准的藥物產品的治療等效性評價(與原開發廠相較)，而所列的學名藥資訊，目的在為醫生，藥劑師和國家衛生機構提供公眾教育和諮詢，並幫助促進獲得價格較低的藥品。

在橘皮書建立後，學名藥廠得藉橘皮書中所登錄之專利新藥的藥品療效、安全性與專利資訊，免去如新藥上市申請所應進行的大規模臨床試驗，僅須提供包括生體相等性（bioequivalent, BE）等資訊之實驗報告，而以較簡易的程序加速其上市，此即Hatch-Waxman Act 之下的「簡易新藥申請程序」（Abbreviate New Drug Application，簡稱ANDA），大幅減省學名藥的試驗成本並加速學名藥的上市審查。

另外，學名藥品之申請者，即ANDA藥品許可證申請人，依據橘皮書上所列的專利資訊，須確保其申請上市之藥品並未侵害目前與該藥品有關之有效專利，否則即無法取得藥品許可證。

橘皮書資訊中，FDA除了提供藥品上市許可以及具治療等效性評估資訊之外，相關的專利資訊主要由新藥申請人提供。

FDA要求新藥申請人，應提供與其藥品有關之專利資訊予 FDA， FDA 將於核發新藥許可後，將此等專利資訊揭露於橘皮書中。而 FDA 對於執行橘皮書上專利資訊的正確與否，亦未擔負任何責任；僅有專利權人和法院才有權利決定刪除及修改橘皮書上之專利資訊。

美國專利商標局(USPTO) 在美國執行專利連結制度並沒有任何的角色參與，也不曾因此需要接受法院或是 FDA 的諮詢，避免包括 FDA 及 USPTO 行政機關直接介入。美國專利連結制度將專利資訊之監督及制衡功能，建立在原開發藥廠及學名藥廠相互監督之關係。

#有關橘皮書與專利連結制度的關係，將於下次專欄加以說明，敬請期待!

<台灣光鹽生物科技學苑編輯>
專欄文章全文連結:http://www.biotech-edu.com/hot_210868.html

台灣光鹽生物科技學苑

About author

這個學苑,不僅有生技製藥產業職場從業人員實務培訓課程, 也有最能思考激盪的學習氛圍,還有認真堅持的學員!

看過「fda orange book」的人也都在關心：

fda orange book 在台灣光鹽生物科技學苑 Facebook 八卦

By 台灣光鹽生物科技學苑

2017-04-22 08:00:00 有 71 人按讚

<#學員分享文>-生技醫藥專利權: 一場橫跨法理與醫藥的戰爭

「2017/04/08-05/13【生技醫藥專利人員培訓班】-週末班」

#新藥專利權 #資料專屬權 #專利法規 #產業分析 #專利人員證照 #著作權法 #營業秘密法 #橘皮書 #紫皮書

(生命科學研究所-在學生上課心得分享)

談到新藥產業，就令人想到每一種專利藥(brand name drug)一年動輒數十億到數百億美金的市場，使得成千上萬的從業人員無不日以繼夜地投入新藥的研究，然而在這些從動物到臨床試驗所耗費十年以上的開發期，沒有完整的專利保護，將可能使過去投入開發新藥的資金化為泡影，因此深入了解新藥專利權及資料專屬權的布局，將是醫藥品從業人員必須知曉的課題。

感謝光鹽學苑開設了這次長達六周結合三位專家的專利培訓班，從專利法規到產業分析，帶來從基礎專利知識到檢索實務的深入培訓，首周的課程由蔡佩珊執行長帶領我們包含專利從業人員的職涯與證照考試，並剖析了專利權在整個醫藥產藥上的角色，上午的課程也使我了解不同智財課題在整個智慧財產權中專利法，著作權法，營業秘密法等三法的區別及各所扮演之功能，使我面對相關的智財議題能更從容的分析與判斷，下午的課程更是著重在精采的實務演練，蔡執行長帶領我們按部就班的分析FDA橘皮書(Orange Book)上市藥品的專利權布局及資料專屬權保護時限以及關於生物藥紫皮書(Purple Book)未來可能探討的方向，使我們在不同專利藥及學名藥的專利比較上能更快得上手實作分析，課程中也帶領我們了解最新的專利法規實務，面對未來藥事法可能修法建立的專利連結制度，原廠與學名藥廠其立場對立所產生的矛盾糾葛，蔡執行長引導我們分析雙方在這項制度建立後可能面對的優勢與劣勢以及從產官學界的視野上來探討如何因應與應對。

生技醫藥專利權的布局與訴訟，這是一場橫跨法理與醫藥的戰爭，身為醫藥產藥的研究人員，過去我都一直以為專利離我有點遙遠，上完這次第一周的課程使我驚覺原來專利一直圍繞在整個產業鏈上，保護著我們所研發出來的成果，因此使我更期待能在接下來的課程學習到更多專利上的知識與實務。

Tags: fda orange book 學員分享文新藥專利權資料專屬權專利法規產業分析專利人員證照著作權法營業秘密法橘皮書紫皮書

台灣光鹽生物科技學苑

About author

這個學苑,不僅有生技製藥產業職場從業人員實務培訓課程, 也有最能思考激盪的學習氛圍,還有認真堅持的學員!

看看搜尋的結果吧：

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FDA –2020–N–1127]. Listing of Patent Information in the. Orange Book; Establishment of a. Public Docket; Request for Comments;.

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The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant seeking FDA approval for a generic version of Synera prior ...

#76. FDA Opens Useful Dialogue On Orange Book Patent Listings

The FDA's opening of a dialogue on which patents are required to be listed in the Orange Book is an acknowledgment of the increasing complexity ...

#77. Will purple become the new orange? The new FDA purple ...

2014, the US FDA published its first edition ... well-established 'Orange Book' counterpart, ... new FDA purple book for biologics: what.

#78. 美国FDA Orange Book（橙皮书）《经过治疗等效性评价批准 ...

橙皮书即《经过治疗等效性评价批准的药品》（Approved Drug Products with Therapeutic Equivalence Evaluations），简称Orange Book，收录经由FDA ...

#79. FDA awards $6M Orange Book Modernization task to Booz ...

Booz Allen Hamilton beat out one other bidder to pick up a 2-year Orange Book modernization task with the Food and Drug Administration.

#80. FDA Orange Book Express 2.0 - iMedicalApps

The FDA Orange Book Express 2.0 is a handy free guide to information on new drug patents, discontinued drug patents, and other patent ...

#81. Avanir Pharmaceuticals Announces Listing Of Additional ...

The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant, seeking FDA approval for a generic version of NUEDEXTA ...

#82. INSIGHT: Drug Delivery Devices in the FDA Orange Book ...

INSIGHT: Drug Delivery Devices in the FDA Orange Book After In re Lantus. By Jason P. Cooper, Zachary A. Higbee, and Madeline E. Byrd.

#83. Orange Book Definition: 209 Samples | Law Insider

Define Orange Book. means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time.

#84. FDA Issues Request for Comments on Modernizing Patent ...

Generic firms filing ANDAs often certify to the FDA that patents listed in the Orange Book are either invalid, unenforceable or will not be ...

#85. Orange Book Q&A Document Provides Insight to the Mysteries ...

The Movement of Drug Products Between the Active and Discontinued Sections of the Orange Book; Patent Listings and patent disputes. The FDA ...

#86. Congress Votes on Amending Orange and Purple Books in ...

The House of Representatives has passed a pair of bills that make changes to the FDA's Orange Book and Purple Book, which provide ...

#87. New HETLIOZ Patent Listed in the FDA Orange Book - Sleep ...

Prior to this newly listed '977 patent, the HETLIOZ Orange Book listed patent with the latest expiry date was set to expire in May 2034.

#88. What Are Purple and Orange Books? - Freyr Solutions

Purple book is a list of innovator biological products, including biosimilars and interchangeable biological products licensed by FDA under the PHS Act and ...

#89. Orange Book Blog

At the Intersection of Patent Law and FDA Law.

#90. An Invasive Launch of Two Compendiums: Orange Book and ...

This article particularly focuses on the Orange Book which is more formally known as ... In addition to this it also reviews the FDA's Purple Book in detail.

#91. US FDA introduces patent submission date updates to Orange ...

US FDA introduces patent submission date updates to Orange Book ... The US Food and Drug Administration (FDA) introduced an important data update ...

#92. FDA

Our Services For Products and Establishments registration at FDA Verification PortalCheck the List of Approved FDA Authorizations Go to Verification Portal ...

#93. Vanda Announces Listing of a New HETLIOZ® Patent in the ...

<< Back Vanda Announces Listing of a New HETLIOZ® Patent in the FDA Orange Book. WASHINGTON , July 2, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc.

#94. Opiant Pharma Announces FDA Orange Book Listing For New ...

Opiant Pharma Announces FDA Orange Book Listing For New NARCAN Nasal Spray Patent - read this article along with other careers information, ...

#95. Old editions of the FDA Orange Book - PIUG Space - Global Site

Does anyone know where I can find the old editions of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (a.k.a. the Orange ...

#96. Listing of Patent Information in the Orange Book - Regulations ...

Notice; reopening of comment period. Summary. The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the ...

#97. Important Terms - Clinical Pharmacology

... dependence relative to the drugs or other substances in schedule IV. FDA Pregnancy Risk Categories ... Orange Book Therapeutic Equivalence (TE) Codes.

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