“We believe that this issued patent complements and expands our intellectual property protection for ferumoxytol, providing further specific claims related to approved dosing and formulation,” commented
AMAG now has four Orange Book listed patents for ferumoxytol, with patent protection through 2020, without patent term extension. AMAG has applied for a patent term extension for an Orange Book listed ferumoxytol patent, which would lengthen that patent term through
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: the approval of the supplemental new drug application Feraheme for a broader patient population; the intended expansion and focus of AMAG’s product portfolio; the company’s intent to drive organic growth of Feraheme; the company’s plans to seek complementary commercial products to add to its portfolio; and the term of and the company’s expected timing on approval of certain patent term extensions are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding our and Takeda’s ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to compete in the oral mucositis market in the US, (3) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to our patents and proprietary rights both in the US and outside the US, (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the
We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Rienso is a registered trademark of
CONTACT: AMAG Pharmaceuticals Contact:
Amy Sullivan, 617-498-3303