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The Orange Book is available online for free. This makes it easy for medical professionals to search for generic equivalents to brand-name drugs, drug patents, and drug exclusivity.
Given that a relatively minor amendment to the Hatch-Waxman Act could give the FDA the authority it requires to assess patents submitted for Orange Book listing and to reject inappropriate patents ...
Orange Book listed patents were subclassified by type according to the “Drug Substance” and “Drug Product” flags and Use Codes listed in the Orange Book.
Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agency’s challenge to dozens of patent listings in the U.S ...
Improper Orange Book listings may have distorted the pharma market for decades, the policy statement said. An FTC review of the potential effects of improper Orange Book listings was included in a ...