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12 September 2017Americas

Janssen sues Aurobindo over ANDA

Janssen, a subsidiary of Johnson & Johnson, has sued generics company Aurobindo over the filing of an Abbreviated New Drug Application (ANDA).

The lawsuit, filed at the US District Court for the District of New Jersey, on Thursday, September 7, claimed that Aurobindo had filed an ANDA to seek approval of a generic version of Janssen’s prezista (darunavir) drug.

Prezista is an antiretroviral medication used to treat and prevent HIV/AIDS.

Janssen claimed that the ANDA infringes US patent numbers 8,518,987; 7,700,645: 7,126,015; and 7,595,408.

The ‘645 patent and ‘987 patent are called “Pseudopolymorphic forms of a HIV protease inhibitor”.

The '015 patent and the '408 patent claim processes for the preparation of bis-tetrahydrofuran, an essential component of darunavir.

Janssen stated that the manufacturing and selling of the ANDA drug would infringe all of the patents.

According to the claim, Janssen had received notice of the ANDA from Aurobindo in July this year, and had requested samples of the product, which Aurobindo agreed to.

But, according to the claim, Aurobindo has not yet sent the products.

Janssen said: “Aurobindo's withholding of needed manufacturing information has impeded Janssen's ability to evaluate infringement of the ‘015 and ‘408 patents.”

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