Eli Lilly 2015 Annual Report Download - page 28

F16
FINANCIAL REPORT
16
• We depend on products with intellectual property protection for most of our revenues, cash flows,
and earnings; we have lost or will lose effective intellectual property protection for many of those
products in the next several years, which may result in rapid and severe declines in revenues.
A number of our top-selling human pharmaceutical products have recently lost, or will lose in the next
several years, significant patent protection and/or data protection in the U.S. as well as key countries
outside the U.S., as illustrated in the tables below:
Product
U.S. Revenues
(2015)
($ in millions)
Percent of
Worldwide
Revenues
(2015) Patent / Data Protection - U.S.
Cialis $ 1,256.8 6% Compound and use patents November 2017
Alimta 1,162.4 6% Compound patent plus pediatric exclusivity January 2017;
vitamin regimen patent plus pediatric exclusivity 2022
Forteo 612.4 3% Formulation and related process patents 2018; use patents
2019
Strattera 502.1 3% Use patent plus pediatric exclusivity May 2017
Effient 417.6 2% Compound patent April 2017; use patents 2023
Product
Revenues
Outside U.S.
(2015)
($ in millions)
Percent of
Worldwide
Revenues
(2015) Patent / Data Protection - Major Europe / Japan
Alimta $ 1,330.7 7% Major European countries: compound patent December 2015,
vitamin regimen patent 2021
Japan: compound patent December 2015, use patents to treat
cancer concomitantly with vitamins 2021
Cialis 1,053.9 5% Major European countries: compound patent November 2017
Cymbalta 883.0 4% Major European countries: data package protection 2014
Japan: data package protection 2018
Zyprexa 783.6 4% Japan: Patent for schizophrenia December 2015; for bipolar
mania April 2016
Forteo 735.9 4% Japan: Data package protection 2018; formulation and related
process patent 2019
Certain other significant products no longer have effective exclusivity through patent protection or data
protection. For non-biological products, loss of exclusivity (whether by expiration or as a consequence of
litigation) typically results in the entry of one or more generic competitors, leading to a rapid and severe
decline in revenues, especially in the U.S. Historically, outside the U.S. the market penetration of generics
following loss of exclusivity has not been as rapid or pervasive as in the U.S.; however, generic market
penetration is increasing in many markets outside the U.S., including Japan, Europe, and many countries
in the emerging markets. For biological products (such as Humalog, Humulin, Erbitux, and Cyramza), loss
of exclusivity may or may not result in the near-term entry of competitor versions (i.e., biosimilars) due to
development timelines, manufacturing challenges, and/or uncertainties in the regulatory pathways for
approval of the competitor versions. See “Management’s Discussion and Analysis—Executive Overview
—Other Matters,” and "Business—Patents, Trademarks, and Other Intellectual Property Rights," for more
details.