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CDE Consults on the First Batch of Drugs for Which Patent Has Expired

 John Li  2017-11-14    2017-11-24

The Center for Drug Evaluation (CDE) affiliated with CFDA has published the first batch of drugs for which the patents have expired or been terminated for public consultations. Those drugs are regarded as having clinical value. However, they have never been launched on Chinese market. This is one of CFDA's efforts to encourage local producers to develop those drugs and improve the public's drug accessibility. Industry can submit their comments to CDE before 25 Nov 2017.

List of Drugs for Which Patents Have Expired

Index

EN Name

CN Name

First Launch

First Launch Date

CN Patent No

Expiration Date

Company

Indications

1

Tavaborole

他伐硼罗

美国USA

2014/7/7

CN1068005C

2015/5/26

Anacor

甲癣

2

Ingenol Mebutate

巨大戟醇甲基丁烯酸酯

美国USA

2012/1/23

/

/

Leo

光化角质病

3

Eliglustat Tartrate

依鲁司他

美国USA

2014/8/19

/

/

Genzyme

戈谢病

4

Laninamivir Octanoate Hydrate

辛酸拉尼米韦

日本JP

2010/9/10

CN1127494C

2017/7/22

Daiichi Sankyo

流感病毒感染

5

Amifampridine Phosphate

磷酸阿米吡啶

欧盟EU

2009/12/23

/

/

BioMarin

肌无力综合征

6

Oritavancin Diphosphate

奥利万星磷酸盐

美国USA

2014/8/6

CN1071334C

2015/1/27

The Medicines Company

细菌性皮肤和皮肤结构感染, 软组织感染, 革兰氏阳性细菌感染

7

Lomitapide Mesylate

甲磺酸洛美他派

美国USA

2012/12/21

CN1108301C

2016/2/1

Aegerion

纯合子家族性高胆固醇血症, 高胆固醇血症

8

Tetrabenazine

四苯喹嗪

美国USA

2008/8/15

/

/

Valeant

亨廷顿氏舞蹈症

9

Glycerol Phenylbutyrate

苯丁酸甘油酯

美国USA

2013/2/1

/

/

Hyperion Therapeutics

尿素循环代谢障碍

10

Uridine Triacetate

尿苷三乙酸酯

美国USA

2015/9/4

/

/

Wellstat

遗传性乳清酸尿症, 化疗引起的中毒

关于征求《首批专利权到期、终止、无效尚且无仿制申请的药品清单》意见的通知

为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字?2017?42号)的要求,引导仿制药研发生产,提高公众用药可及性,我中心组织对国内化合物专利权到期、终止、无效且尚无仿制申请的国外已上市药品进行筛选,初步筛选出他伐硼罗等10个具有明确临床价值的药品,拟纳入《首批专利权到期、终止、无效尚且无仿制申请的药品清单》。现向社会公开征求意见。对10个品种专利权属状态有异议的,请于2017年11月25日前,通过电子邮件提出意见并说明理由。

联系人:李逸云;邮箱地址:liyy@cde.org.cn。

Reference

http://www.cde.org.cn/news.do?method=viewInfoCommon&id=313982

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