Being the first to launch a generic into the market grants a drugmaker 180 days of market exclusivity. However, with so many companies pursuing that goal, the first-filer status is often shared among several companies.
“Generally [generic] clients see it as a negative if they file an ANDA on the NCE-1 date and learn there’s another eight, 10 or 15 filers. That changes their calculus,” Gary Hood, a Chicago-based lawyer, told Bloomberg Law. “They may not view this as the opportunity they thought it was.”
An excess of competing generic drugmakers can catalyze more legal action for brand-name drugmakers in defense of their patents. Generic drugmakers often engage in patent battles so they can reach agreements with brand-name drugmakers that give them compensation to stay away from the market. As a result, even all the competition among drug manufacturers doesn’t mean patients will see lower drug costs.
Other generic drugmakers are focusing on pursuing first-filer status for only hard-to-manufacture drugs, such as injectable medications, since fewer companies are able to produce those.
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Kaiser Permanente joins Civica Rx to supply generic drugs
New CMS rule promotes payer drug price negotiations based on clinical outcomes
Nearly 90% of Americans worried about drug price hikes
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