Drugmaker Eli Lilly and Co. (LLY) said Friday that it has obtained six months U.S. pediatric exclusivity for Cymbalta or duloxetine Hcl, from the U.S. Food and Drug Administration (FDA). The approval will see Lilly gain an additional six months of U.S. market exclusivity for Cymbalta, which now will expire in December 2013.
Cymbalta is indicated for the management of chronic musculoskeletal pain due to chronic osteoarthritis pain and chronic low back pain as well as for management of diabetic peripheral neuropathic pain and fibromyalgia. It is also approved to treat major depressive disorder and generalized anxiety disorder.
Cymbalta, a serotonin and norepinephrine reuptake inhibitor (SNRI), is FDA-approved only for use in adults aged 18 and older. It is available in 20-mg, 30-mg, and 60-mg capsules.
Pediatric exclusivity does not mean that Cymbalta is approved for use in pediatric patients. Lilly said it will also not seek a pediatric indication for Cymbalta based on study results. Pediatric exclusivity is an add-on to existing marketing exclusivity or patent protection.
This exclusivity extensions is provided if the drug manufacturer submits certain FDA-requested information relating to the use of the active moiety in a pediatric population. This permits certain new drug applications to obtain an additional six months of exclusivity.
The FDA may issue a request for pediatric studies at the drug sponsor's request or on its own initiative. Pediatric exclusivity grants an additional six months of market protection at the end of listed patent(s) and/or other exclusivity terms for all drug products containing the active moiety.
Lilly's Zyprexa has already lost patent exclusivity in the U.S. and most major international markets outside of Japan.
LLY closed Thursday's regular trading session at $42.85, down $0.20 on a volume of 3.76 million shares.
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