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新基的争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 8 条

  1. 2021

    Celgene就药物专利起诉Biocon Pharma

    提起诉讼

    Celgene Corporation在新泽西地区法院起诉Biocon Pharma,指称Biocon可能推出的仿制药会侵犯Celgene的专利。Celgene请求包括禁令及延后仿制药批准生效日期等救济;报道所述为指控,并非法院认定。

    来源摘录

    • On Friday, Celgene Corporation filed a complaint in the District of New Jersey. The case was filed against Biocon Pharma Inc.
    • Celgene alleged that the information submitted to the FDA on its face shows intent to infringe upon the patents held by Celgene and seeks redress.
  2. 2021

    Zydus就美国仿制Revlimid专利诉讼达成和解

    和解

    Cadila Healthcare及其子公司Zydus Pharmaceuticals (USA)(合称Zydus Cadila)宣布与Celgene就Revlimid相关专利达成协议。根据和解安排,各方将向法院提交同意判决,禁止Zydus Cadila在相关专利到期前销售仿制来那度胺,但和解协议另有规定的情况除外。

    来源摘录

    • As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Zydus Cadila from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement.
    • Cadila Healthcare Limited and its subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus Cadila) has announced that they have reached an agreement with Celgene Corporation (Celgene), a wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) relating to patents for REVLIMID® (lenalidomide).
  3. 2020

    Dr. Reddy’s 与 Celgene 就 Revlimid 专利诉讼达成和解

    和解

    Dr. Reddy’s 宣布与 Celgene 就 Revlimid 胶囊专利的诉讼达成和解。根据和解协议,Celgene 同意授权 Dr. Reddy’s 在获得监管批准后,自 2022 年 3 月之后某个保密日期起在美国销售数量受限的仿制来那度胺胶囊,并自 2026 年 1 月 31 日起不受数量限制地销售。

    来源摘录

    • In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval.
    • Dr. Reddy's is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.
    • Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries (together referred to as "Dr. Reddy's"), today announced the settlement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for REVLIMID® (lenalidomide) Capsules.
  4. 2020

    Cipla与Celgene就Revlimid专利诉讼达成和解

    和解

    Cipla宣布与Celgene就Revlimid相关专利诉讼达成和解。和解安排包括同意判决,禁止Cipla在相关专利到期前销售仿制来那度胺(和解条款另有规定的除外);并约定在2022年3月之后某个保密日期起限量销售,以及不早于2026年1月31日起不限量销售。Cipla能否在美国销售该药仍取决于其获得ANDA批准。

    来源摘录

    • Pharma major Cipla on Friday announced the settlement of its patent litigation with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for Revlimid (lenalidomide).
    • In addition, Celgene has agreed to provide Cipla with a licence to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026, the filing said.
    • “As part of the settlement, the parties will file consent judgements with the US District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement,” Cipla said in a filing to BSE.
  5. 2018

    FDA批评样品获取问题

    FDA将新基列为据报道拒绝潜在仿制药制造商获取开发测试竞争产品所需样品的公司之一。

  6. 2017

    涉及Revlimid和Thalomid的《虚假申报法》和解

    新基同意解决政府指控,即其导致对Revlimid和Thalomid的某些用途提交虚假或欺诈性索赔,这些用途不在医疗保险或州医疗补助计划的报销范围内。当代披露描述了包括费用和开支在内的总和解金额。

  7. 2009

    Thalomid样品获取和反垄断争议

    仿制药公司质疑新基拒绝提供Thalomid样品用于生物等效性测试。相关诉讼指控受限分销系统被用来阻碍仿制药竞争;主要案件在审判前和解。

  8. Revlimid定价批评

    新基以及后来的百时美施贵宝因Revlimid价格多次上涨而面临公众批评。具体的价格比较因来源和时间而异;此处未包含财务数字,因为提供的材料没有为所述金额提供可验证的来源URL。