Eli Lilly and Co. (NYSE: LLY) announced on Friday that it met the FDA’s pediatric exclusivity requirements for Cymbalta, the company’s treatment for depression and pain. Based on the FDA’s decision to grant pediatric exclusivity, the company gained an additional 6 months of U.S. market exclusivity for Cymbalta. As a result, patent protection will now expire in December 2013.
Given that paediatric exclusivity is common for most medicines, the extension was largely expected, hence, the lack of significant movement in the shares.
The next major catalyst for LLY is Phase III results for the company’s Alzheimer’s treatment candidate, solanezumab, which are expected later this Summer. Expectations are for lackluster results, hence, the shares are likely to be highly volatile based on the outcome of the Phase III trials.