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21 January 2014Americas

Actavis survives challenge to birth control pill

On January 17, Actavis confirmed that the US District Court for the District of New Jersey found its US patent 7,704,984, which covers Lo Loestrin Fe birth control pills, to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals.

Lupin and Amneal had filed Abbreviated New Drug Applications with the US Food and Drug Administration seeking approval to make generic versions of Lo Loestrin Fe tablets (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate).

Paul Bisaro, Actavis’s chairman and chief executive, said of the decision: “We are pleased that the court has ruled in our favour and upheld the validity of our patent on Lo Loestrin Fe.

“The enforcement of our intellectual property rights is a critical tool in our ability to continue to invest in future treatments, and we intend to vigorously defend these rights against any future challenges or appeals.”

A spokesperson for Lupin told LSIPR: “We as a matter of policy do not comment on ongoing litigations”.

Amneal did not respond to LSIPR’s request for comment.

According to IMS Health Data, for the 12 months ending March 31, 2012, Lo Loestrin Fe had total US sales of about $86 million.

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