Since pitavastatin (Livalo) has just surfaced in discussion on this Board, I thought I might introduce it a little better for those like me that knew little of it before. It is a product of Japanese company Kowa Pharmaceuticals and was approved in 2003 in Japan. It spread over Asia and gained approval in China and the US in 2009. In 2010, they announced a co-promotional agreement with Eli Lilly. Since Kowa is a private company, they are not easy to access data from so I looked to see if Lilly offered anything. Their website does not list it as a product and their 10-K's since never include it in their itemized revenue by product. Japan revenue of Livalo in 2008 was US$380 million and 2010 was US$520 million. 

It is hard to find Livalo data due to it being private but I did find one article stating (can't verify their accuracy) that in 2013, Crestor's market share was 74.6% while combined atorvastatin (Lipitor & generic) was down to 14.7% and Livalo was 1.9%. This was around the time of BETonMACE design so speaks to it not being included in BoM. Livalo might be a victim of being late to the party as one article stated that its advantages were not significant enough to upset standard of care. We have felt that as if I am not mistaken, Apabetalone passed rosuvastatin in ASSURE but not enough to upset standard of care as well as not meeting its target.

Livalo's active ingredient is under patent protection until Dec. 25/20. This was recently challenged by generic manufacturers but it was upheld by the court. That might hold back its growth as patients opt for generic statins. To show that trend, Crestor revenue (from AZ 10-K's) in 2012 was $6.3 bn, 2015 was $4.5 bn,  2016 (patent expiry) was $2.9 bn and 2018 was $1.4 bn. Lipitor was $12.4 bn on patent in 2008 and down to 4.9% as opposed to 9.8% generic in 2013.