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N Engl J Med 2021;385:416-26.ArticlePubMedPMC 937

We see no signals

Pharmacologically, KLOW is mostly given as small subcutaneous injections in research studies, with typical vials containing 50 to 100 milligrams, split into daily or every-other-day doses over 410 week cycles

But many patients are not simply stopping and walking away

The cost and uncertainty of litigating three independent Orange Book-listed patents with different expiration dates through a Paragraph IV challenge exceeds the expected profit margin of a first-filer generic in a specialty drug with a currently finite patient population

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