Sanofi and Lilly Agree To Pursue Regulatory Approval Of Nonprescription Cialis
By Cyndi Root
Eli Lilly and Company announced in a press release that it has made an agreement with Sanofi to pursue regulatory approval of over-the-counter (OTC) Cialis (tadalafil). Currently only available by prescription, Lilly’s Cialis treats erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). The Food and Drug Administration (FDA) approved the drug in 2003 and it is currently available in more than 120 countries.
Vincent Warnery, SVP of Global Consumer Healthcare Division at Sanofi, said the agreement was an “opportunity to forge an industry-leading partnership.” David Ricks, SVP at Lilly said, "Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."
Sanofi and Lilly Agreement
The two companies have agreed to several provisions. Sanofi acquires the right to file for OTC approval in the U.S., Canada, Australia, and Europe. Following regulatory approvals, Sanofi is authorized to commercialize OTC Cialis. Due to expiring patents, the companies did not reveal timetables for the partnership. However, Cialis is due to lose its patent in 2017 in the U.S. and Europe. Sanofi and Lilly did not release financial details.
Cialis
The European Medicines Agency (EMA) approved Cialis in 2002 and the U.S. approved it in 2003 for ED. The FDA approved it for BPH in 2011. The drug is approved in 120 countries for ED and other conditions. Lilly says that sales of Cialis were $2.16 billion worldwide in 2013. Since its launch, Cialis has earned over $14 billion treating more than 45 million men. Cialis is administered orally as needed in dosage strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg for ED, and 5 mg for BPH.
IMS Health Generics Report
IMS Health has released a report detailing the global market for generics from 2012 to 2017. It says that generics will dominate the market by 2017, accounting for 63 percent market share. Patent expiration is driving the growth of OTC drugs. Report authors state that developed markets use branded drugs the most. However, emerging markets are ripe for OTC drug sales.