AMAG Pharmaceuticals Inc. and Novartis AG's Sandoz Inc. unit agreed to settle their patent dispute involving the AMAG's anemia drug Feraheme.
AMAG received a notification from the U.S. Food and Drug Administration when Sandoz filed a Paragraph IV abbreviated new drug application for its generic version of the drug in 2016. In the filing, the generic-drug company said the generic copy does not infringe the listed patents in the FDA's Orange Book, or that such patents are invalid or unenforceable.
If Sandoz wins the FDA's approval by a certain date, the Novartis unit may launch the generic copy July 15, 2021, or earlier under certain circumstances. Sandoz will also pay AMAG a royalty on the generic's sales until the last Feraheme patent listed in the Orange Book expires.
However, if the U.S. regulator rejects Sandoz's application, the company may launch the approved generic version July 15, 2022, for a one-year period.
AMAG believes the settlement allows the continued advancement of Feraheme in the U.S. iron market.