正大天晴布地奈德混悬液首仿正式获批

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-02-28 14:29
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(Summary description)2月26日，NMPA官网公布2020年02月26日药品批件发布通知，正大天晴受理号为CYHS1700633苏的吸入用布地奈德混悬液拿到药品批件，正式获批。目前布地奈德两个重要品种吸入用布地奈德混悬液（商品名：普米克令舒）和布地奈德粉吸入剂（商品名：普米克都保）都来自阿斯利康，根据PDB样本医院数据显示，布地奈德2018年在国内的销售额中阿斯利康占比98.93%，可见其龙头地位。上市其他品种中，气雾

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正大天晴布地奈德混悬液首仿正式获批

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-02-28 14:29
Views:

Information

2月26日，NMPA官网公布2020年02月26日药品批件发布通知，正大天晴受理号为CYHS1700633苏的吸入用布地奈德混悬液拿到药品批件，正式获批。

目前布地奈德两个重要品种吸入用布地奈德混悬液（商品名：普米克令舒）和布地奈德粉吸入剂（商品名：普米克都保）都来自阿斯利康，根据PDB样本医院数据显示，布地奈德2018年在国内的销售额中阿斯利康占比98.93%，可见其龙头地位。上市其他品种中，气雾剂国内有上海信谊百路达和鲁南贝特的产品，粉雾剂有上海信谊百路达的产品，但份额较小。国内已上市布地奈德吸入产品

南京华讯知识产权顾问有限公司

（资料来源：药智网）

布地奈德是一种具有强效糖皮质激素活性和弱盐皮质激素活性的抗炎性皮质类固醇药物，通

过抗炎作用治疗哮喘。吸入疗法是防治哮喘等呼吸道疾病的首选疗法，吸入的药物可直接到达呼吸道和肺部，具有起效快，使用剂量小、毒副作用小等优点。

吸入用布地奈德混悬液属于吸入性糖皮质激素，通过雾化器给药，适应症为治疗支气管哮喘，可替代或减少口服类固醇治疗。原研为阿斯利康的普米克令舒，1991年在英国首次上市，2000年8月获得FDA批准上市，2001年11月获批进入国内市场，规格为2 ml:0.5 mg和2 ml:1 mg。

根据米内网数据，2018年吸入用布地奈德混悬液在样本医院销售额12.46亿元，对应实际市场规模约50亿元，同比增长11.17%，2012-2018年CAGR达19.29%。预计2019年国内销售额突破60亿元，为阿斯利康在国内的最大品种。

在仿制品方面，正大天晴和健康元研发进展原本处于较领先位置，均于2018年3月提交上市申请。而在2018年11月20日，健康元发布公告称，子公司太太药业收到了布地奈德混悬液的《药物临床试验通知书》，重新开展了BE试验，在2019年2月重新递交上市申请。而长风药业于2018年5月申报上市，时间上弯道超车健康元。

正大天晴于2018年3月按化药4类提交了吸入用布地奈德混悬液仿制药（受理号：CYHS1700633、CYHS1700634，分别代表2 ml:1 mg和2 ml:0.5 mg），此次获批的为大规格，即CYHS1700633。本次正大天晴成功拿下了布地奈德混悬液的首仿，将与原研瓜分国内60亿市场。

近年来，正大天晴在首仿药方面的表现备受瞩目。种种迹象显示，“抢首仿”是正大天晴药业一直以来坚持的战略规划，也是公司在市场上巨大的竞争优势。

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Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

2021-10-22

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully!

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Types of patents that are easily overlooked- Design Patent

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Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million

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