目前最畅销的伟哥-他达拉非首仿花落梯瓦
1.他达拉非片（Tadalafil）是环磷酸鸟苷（cGMP）特异性磷酸二酯酶5（PDE5）的选择性，可逆抑制剂，当性刺激导致局部释放一氧化氮，PDE5受到他达拉非抑制，使阴茎海绵体内cGMP水平提高，这导致平滑肌松弛，血液流入阴茎组织，产生勃起，如无性刺激。
2.目前适应症有：勃起功能障碍(ED)、良性前列腺增生症(BPH)。
3. 他达拉非原研礼来(最早由葛兰素威康发现)，商品名为Cialis，中文希爱力，2003年在美国上市， 2016年销售业绩为24.56亿美元，2017年为23.04亿美元。
在美国的MAT（滚动年销售额），从2017年7月到2018年7月，Cialis已经接近19.3亿美元。
4. Teva在2018年9月27日宣布，将在美国独家推出Cialis(他达拉非)的仿制药(2.5毫克、5毫克、10毫克、20毫克)。
5.Teva的他达拉非仿制药已在2017年获得了FDA的暂时性批准（TA），由于专利问题产没有上市。根据礼来与Teva达成的协议将他达拉非的专利期限定为了2018年9月27日。
6.原文：
September 27, 2018 3:00 p.m.
Teva Announces Exclusive First-to-File Launch of a Generic Version of Cialis® in the United States
Sep. 27, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the exclusive first-to-file launch of a generic version of Cialis®1 (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the U.S.
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH).
Teva’s EVP and Head of Global R&D, Hafrun Fridriksdottir said, “We’re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15 million men in the United States.”
Brendan O’Grady, EVP and Head of North America Commercial at Teva added, “This launch represents an important addition to our generics portfolio, building on our exclusive launch of a generic version of Viagra®(sildenafil) tablets last year. We’re committed to ensuring that patients are able to access this medicine.”
With over 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Cialis® had annual sales of nearly $1.93 billion in the U.S., according to IQVIA data as of July 2018.
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参考：
https://www.tevagenerics.com/globalassets/launch-materials/tadalafil/tadalafil-tablets_pi.pdf；
http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2369312；
NMPA/CDE；
药融数据，Pharnex Datamonitor;
FDA/EMA；
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process;
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090141Orig1s000TAltr.pdf;
相关公司公开披露等。
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