爱美津相信他们是首家提交某些规格的Namzaric®（固定剂量美金刚-多奈哌齐复方制剂）简略新药申请的厂家，该申请包含了一个依据药品价格竞争和专利期修正案的法规规定的专利挑战声明（声明IV）

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2017年9月5日

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美国新泽西州林德赫斯特, 2017年9月5日消息-爱美津制药有限公司（爱美津）今天宣布：根据美国FDA的在线数据库信息a，爱美津相信我们是首家提交7/10b 和 21/10c的Namzaric®（固定剂量美金刚-多奈哌齐复方制剂）简略新药申请的厂家，该申请包含了一个依据药品价格竞争和专利期修正案的法规规定的专利挑战声明（声明IV）。Allergan目前在有4个规格的Namzaric产品在美国上市，用于治疗与阿尔茨海默氏病有关的痴呆症，根据IMS Health提供的数据，至2017年6月底的3个月内销售额达到约5200万美元。 Allergan公司和Amerigen公司在2016年10月份就Amerigen公司的“Namzaric®”ANDA申请所引发的所有诉讼达成和解协议。

备注(a) 具体参考FDA的药物产品清单，FDA仿制药办公室收到了包含声明IV的ANDA申请。

备注(b) 7/10代表包含7mg缓释盐酸美金刚和10mg盐酸多奈哌齐的胶囊。

备注(c) 21/10代表包含21mg缓释盐酸美金刚和10mg盐酸多奈哌齐的胶囊。

LYNDHURST, N.J., Sept. 5, 2017 — Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that, based on the August 7th, 2017 update to the U.S. Food & Drug Administration’s online databasea , the Company believes that it is a first applicant to file an Abbreviated New Drug Application (“ANDA”) for Namzaric® 7/10b and 21/10c containing a “Paragraph IV” patent certification under the provisions of the Hatch-Waxman Act. Allergan currently markets 4 strengths of Namzaric® in the U.S. for the treatment of dementia associated with Alzheimer’s Disease, which collectively generated approximately $52 million in sales in the 3 months to the end of June 2017 according to data provided by IMS Health. Allergan and Amerigen reached a settlement agreement with respect to all litigation arising from Amerigen’s ANDA for Namzaric® in October 2016.

Note (a) Specific reference is made to the FDA’s list of drug products for which an ANDA has been received by the Office of Generic Drugscontaining a “Paragraph IV” patent certification.
Note (b) 7/10 represents a capsule containing 7mg of Memantine Hydrochloride extended release and 10mg of Donepezil Hydrochloride.
Note (c) 21/10 represents a capsule containing 21mg of Memantine Hydrochloride extended release and 10mg of Donepezil Hydrochloride.

关于爱美津 About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

爱美津制药致力于仿制药所涉及到的全部阶段的业务，是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州，林赫斯特的美国爱美津负责；集团的中国分公司，苏州爱美津制药有限公司，位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售，同时，我们拥有活跃的在研产品组，面向美国食品药品监督管理局（FDA）注册和已申报若干个仿制药品种（ANDA），并且计划开展向中国食品药品监督管理局（CFDA）注册和申报产品的工作。爱美津从事开发的口服制剂产品，是开发难度高，需要专门的技术，或生产要求高度严格管理控制，以及法规复杂，需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品，都满足高质量标准，包括美国FDA。