Viatris : FDA Grants Tentative Approval Of Budesonide/formoterol Fumarate Dihydrate Products


2021-03-09 00:52:53 RTTNews


Viatris Inc. and Kindeva Drug Delivery L.P. said that the U.S. Food and Drug Administration granted tentative approval of budesonide/formoterol fumarate dihydrate products. It is the first generic version of Symbicort based on an Abbreviated New Drug Application or ANDA. Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The FDA provided tentative approval at this time due to ongoing patent litigation. On March 2, 2021, the U.S. District Court for the Northern District of West Virginia found that the asserted claims of AstraZeneca's Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137, are not invalid for obviousness. Viatris and Kindeva noted that the trial court decision prevents commercial launch at this time. But, they intend to file an appeal to continue vigorously defending their position that the patents are invalid. They are committed to bringing a generic Symbicort to market as soon as possible. Viatris said it has not planned any revenue for 2021 from generic Symbicort, and the product's potential launch revenue was not included in the company's recently announced 2021 financial guidance. Symbicort had U.S. branded sales of $3.5 billion for the 12 months ending January 2021, according to IQVIA. For comments and feedback contact: Business News
Viatris公司和Kindeva Drug Delivery L.P.称美国食品药品监督管理局给予布地奈德/富马酸二水福莫特罗产品暂定批准。它是基于缩写新药申请或ANDA的Symbicort的第一个通用版本。 Symbicort用于某些哮喘或慢性阻塞性肺疾病(COPD)患者。 由于正在进行的专利诉讼,FDA此时提供了暂定批准。 2021年3月2日,美国西弗吉尼亚州北区地方法院裁定,阿斯利康的Symbicort专利,即美国专利第7,759,328、8,143,239和8,575,137号的权利主张不因明显而无效。 Viatris和Kindeva指出,审判法院的裁决阻止了商业发射。但是,他们打算提起上诉,继续有力地维护他们的专利无效的立场。他们致力于尽快将通用的Symbicort推向市场。 Viatris表示,它还没有计划在2021年从通用型Symbicort获得任何收入,该产品的潜在推出收入也没有包括在公司最近公布的2021年财务指导意见中。 根据IQVIA的数据,在截至2021年1月的12个月里,Symbicort在美国的品牌销售额为35亿美元。 如需评论和反馈,请联系 商业新闻