法德藥精神病用藥申請FDA 中央社 (2014-03-02 18:03)（中央社記者羅秀文台北2014年3月2日電）法德藥(4191)今天宣布，抗精神分裂症用藥Quetiapine Fumarate ER Tablet已向美國食品藥物管理局(FDA)提出第4類學名藥(P IV)上市審查申請。法德生技藥品成立於2008年，主要從事特殊學名藥的研究與開發工作，尤其是困難學名藥(Difficult-To-Formulate)及挑戰美國FDA第4類(Paragraph IV, P IV)和首仿(First-To-File)學名藥(ANDA)的上市申請。法德藥表示，Quetiapine Fumarate ER Tablet是一種長效型抗精神分裂症(Schizophrenia)用藥產品，商品名稱為Seroquel XR，原開發廠是阿斯利康製藥(AstraZeneca)。根據2012年的銷售資料顯示，原廠藥在美國市場年銷售額約12億美元，是一個重量級產品。此外，法德藥表示，去年12月下旬已接獲美國通路商對長效降血壓藥MetoprOLol Succinate ER Tablet產品的訂單，預計今年獲得FDA最終上市核准函後，產品將在美國上架銷售，正式邁入營收階段。
拚P4！法德藥長效抗精神分裂症學名藥向FDA遞件 鉅亨網新聞中心 (來源：精實新聞) 2014-03-03 07:59:18精實新聞 2014-03-03 記者 蕭燕翔 報導法德藥(4191)宣布，長效抗精神分裂症學名藥Quetiapine Fumarate(150mg,200mg,300mg,400mg ER Tablet)向美國食品藥物管理局(US FDA)提出第四類學名藥(P IV)上市審查申請(遞件)，這也是該公司繼長效型降血壓用藥後的另一P4代表作。 Quetiapine Fumarate ER Tablet是一種長效型抗精神分裂症(Schizophrenia)用藥產品，商品名為Seroquel XR，其原開發廠為阿斯利康製藥(AstraZeneca)。根據2012年的銷售資料顯示，原廠藥在美國市場年銷售額約12億美元，屬年銷10億美元以上的Blockbuster。且這也是法德藥繼2011及2012年成功開發長效型降血壓用藥Metoprolol Succinate ER Tablet產品(商品名：Toprol XL)後，又一成功力作。法德生技藥品成立於2008年，主要從事特殊學名藥的研究與開發工作，尤其是困難學名藥（Difficult-To-Formulate）及挑戰美國FDA第四類（Paragraph IV, P IV）和首仿（First-To-File）學名藥（Abbreviated New Drug Application, ANDA）的上市申請。該公司創業核心成員在製藥產業已累計超過三十年藥品研發經驗，專精在長效固體劑型產品(Extended-Release Dosage From)開發領域，更是國內少數具實際成功開發美國學名藥產品(ANDA)經驗的專業團隊，該公司2011年及2012年即成功開發極具市場潛力長效降血壓用藥及抗糖尿病用藥等產品，分別向美國FDA申請ANDA送件。2013年7月美FDA針對法德100%轉投資的中國廣東佛山里水廠進行產品上市前的查廠（Pre-Approval Inspection,PAI），獲得零缺失（No Observation）的高標評價通過。法德藥於2013年12月下旬已接獲美國通路商對長效降血壓藥Metoprolol Succinate ER Tablet產品的訂單，預計今年(2014)接獲FDA最終上市核准函後，產品即同步在美上架銷售，正式邁入營收階段。
Par Pharmaceutical Acquires Rights to Market and Distribute Generic Seroquel XR® in the U.S. WOODCLIFF LAKE, N.J., Oct. 29, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC to acquire Handa's Abbreviated New Drug Application (ANDA) for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca's Seroquel XR®. Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes a 400 mg dosage strength. Under the terms of the agreement, Par has made a payment for the ANDA and for exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Par will receive a share of profits from the sales of the product. Under the terms of a prior settlement agreement with AstraZeneca, which has been assigned to Par, Par has a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. SOURCE Par Pharmaceutical Companies, Inc.
AstraZeneca in patent settlement deal with Handa over Seroquel XR
30-09-2011 Anglo-Swedish drug major AstraZeneca (LSE: AN) yesterday revealed that it has entered into a settlement agreement in its US Seroquel XR (quetiapine) patent infringement litigation against California, USA-based Handa Pharmaceuticals, regarding Handa's proposed generic version of the blockbuster drug, which is indicated for the treatment of depression and bipolar disorder. Handa was the first company to file an Abbreviated New Drug Application with the US Food and Drug Administration, gaining tentative approval on December 13, 2010, for 50, 150, 200 and 300mg tablets of Seroquel XR and said it believed it was the first to file a Paragraph IV containing certification under the provisions of the Hatch-Waxman Act, which would give the copy drugmaker 180 days of marketing exclusivity for these tablet strengths on receipt of final regulatory approval. AstraZeneca is still pursuing patent law suits against five other generic drugmakers, including Mylan, over Seroquel XR, US sales of which were around $750 million last year. Total turnover of Seroquel reached $5.3 billion last year, with around $4 billion coming from the USA.
Handa can now launch generic on November 1, 2016 Under the agreement, also referred to as a pay-for-delay deal, Handa does not dispute that both patents asserted by AstraZeneca in the US patent litigation are valid and enforceable. As part of the accord, AstraZeneca has granted Handa a licence to enter the US market with generic Seroquel on November 1, 2016 or earlier upon certain circumstances. Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017. AstraZeneca and Handa will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining Seroquel XR patent infringement litigations remain on-going. "We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time. Seroquel XR remains an important part of our company's portfolio benefiting patients and physicians throughout the world,"said David Brennan, chief executive of AstraZeneca. This settlement will have no impact on the company's full year 2011 financial guidance, AstraZeneca noted.
Posts
No comments:
Post a Comment