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辉瑞允许梯瓦于今年12月推出其重磅止痛药西乐葆仿制药

发布时间:2014年04月22日 14:44:58

西乐葆用于治疗关节炎疼痛和炎症,根据辉瑞提供的信息,这款药物在2013年的销售额达到29.2亿美元。梯瓦是世界上最大的仿制药制造商,该公司认为它是首家提交西乐葆三种规格仿制药上市申请的公司。美国FDA通常给予首个提交上市申请的仿制药商180天的市场独占权。

 

辉瑞于4月17日表示,该公司将继续捍卫其专利权,该专利由美国专利与商标局于三月份授予,将西乐葆的市场独占权延长到2015年12月2日。“这次对梯瓦的许可将收取专利权使用费,直到剩余专利期结束(2015年12月2日),”一位辉瑞发言人在电子邮件声明中这样称。“和解协议的其余条款是保密的。”

 

辉瑞起诉了几家制药商,包括迈兰制药和阿特维斯制药,这两家公司也在寻求美国FDA批准销售他们的西乐葆仿制药。西乐葆的基本化合物专利于5月30日到期。

 

Teva, Pfizer settle patent lawsuit over blockbuster painkiller

 

A man walks past the Pfizer logo next to a New York Police Officer standing outside Pfizer's world headquarters in New York November 5, 2013. REUTERS/Adam Hunger

 

A man walks past the Pfizer logo next to a New York Police Officer standing outside Pfizer's world headquarters in New York November 5, 2013.

 

Teva Pharmaceutical Industries Ltd said it settled apatent lawsuit with Pfizer Inc, allowing the Israeli drugmaker to launch a generic version of Pfizer's blockbuster painkiller Celebrex in December.

 

In March, a U.S. court invalidated a patent covering Celebrex, giving Pfizer's rivals a chance to sell cheaper versions. Pfizer had said it would appeal the ruling.

 

The drug, which is used to treat arthritis pain and inflammation, generated ab0ut $2.92 billion in sales in 2013, according to Pfizer's annual regulatory filing.

 

Teva, which is the world's largest generic drugmaker, said it believed it was the first to file for an approval of a generic of three dose strengths of Celebrex.

 

The U.S. Food and Drug Administration usually grants first-to-file drugmakers 180 days ofmarketing exclusivity.

 

Pfizer said on Thursday it would continue to defend the patent, which the U.S. Patent and Trademark Office granted in March, extending its marketing exclusivity until December 2, 2015.

 

"Under certain conditions, the license will be royalty-bearing, through the remaining term of the patent (December 2, 2015)," a Pfizer spokesman told Reuters in an emailed statement. "The remaining terms of the settlement are confidential."

 

The company sued several drugmakers, including Mylan Inc and Actavis Inc, which are also seeking U.S. regulatory approval to sell their generic versions of Celebrex.

 

Celebrex's basic chemical patent expires on May 30.

 

Teva's shares were up 1 percent at $50.43 in early trading on the New York Stock Exchange, while Pfizer's shares were little changed at $30.11.

 

 

 

 

 

 

 

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