Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if enacted, will require brand pharmaceutical companies to submit more information about their innovator products. Potential Changes to Orange Book Listing Requirements for Non-Biologics Drugs As part of its current obligations, an innovator product manufacturer must submit to the FDA the patent number and expiration date of any patents that claim the drug or a method of using the drug. The FDA then performs the ministerial function of listing the information in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. The Hatch-Waxman Act permits generic manufacturers to file a counterclaim to delist a patent that they believe is improperly listed. Over the years, FDA has issued technical regulations expanding...

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