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【原创】杨森、Eon为斯皮仁诺通用名药法庭相见
美国FDA最近批准了Eon实验室的三唑类抗真菌药伊曲康唑（itraconazole）100mg胶囊剂，该品系杨森(Janssen，J&J)公司斯皮仁诺（Sporanox）的通用名药。在给Eon的批准函中，FDA确认Eon是斯皮仁诺的第一个仿制药简化新药申请(ANDA)者，其伊曲康唑100mg 胶囊剂已具备享有180天市场独占权的资格，起效时间从产品上市或法院宣判日开始。
然而，该品虽获得了FDA的首肯，却因杨森公司的起诉而无法立即上市。
杨森公司指出，根据No 5,633,015美国专利, 斯皮仁诺的专利保护应到2019年5月才到期，Eon的通用名药越位抢滩属于侵权行为。Eon在随后的应诉答辩中，声称依据ANDA条款IV认证（Paragraph IV certification），并未构成对斯皮仁诺专利的侵犯。
受理该官司的美国纽约州地方法院已于最近完成对双方的听讼等初始程序，案审尚在有条不紊地进行中，鹿死谁手不得而知。
Eon gains final FDA approval for generic Sporanox, but litigation continues
The US FDA has granted final approval to Eon Laboratories' itraconazole 100mg capsules, a generic version of Janssen's Sporanox, but the product is still the subject of litigation and will not be launched immediately. Janssen (J&J) claims a US patent, No 5,633,015, protects the product until May 2019. Eon filed a Paragraph IV certification with its ANDA stating that it believes it does not infringe the '015 patent, or that this is otherwise invalid or unenforceable; the company was subsequently sued by Janssen. A consolidated trial and preliminary injunction hearing were recently completed in a US district court in New York and a decision from the court is pending, Eon says. In its approval letter to Eon, the FDA confirms that Eon was the first ANDA applicant to submit a Paragraph IV certification to the '015 patent, and is therefore entitled to 180 days of market exclusivity for the 100mg capsule product. The exclusivity period begins either on an appellate court decision or once the product is launched.
Full title: SCRIP - World Pharmaceutical News
FILED 8 June 2004 COPYRIGHT 2004 PJB Publications Ltd [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-19 17:14
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