Showing posts from January, 2019

Orange Book Aficionados: Do Not Neglect Patent Listings for the Discontinued Strengths of Your Marketed Drugs

Just a little reminder that drugs with a marketing status of “Discontinued” in the FDA’s Orange Book should have up-to-date patent listings. Patent listings for discontinued strengths are especially important when there are strengths of the drug that are still being marketed. Without listed patents, an ANDA approval (if the strengths were not discontinued for safety or efficacy reasons) or a 505(b)(2) approval could occur without warning based on a Paragraph I or a “no relevant patents” certification.
When I was testing new code to add patent submission dates to myOrange Book CompanionI discovered that Sun Pharmaceuticals’ XIMINO (minocycline HCl) had marketed strengths with listed patents and discontinued strengths without any listed patents. XIMINO was originally approved under 505(b)(2) with five equally spaced strengths: A-E. Later the two intermediate strengths, B and D, were discontinued. Seven patents are now listed for strengths A, C and E, but no patents are listed for interme…