US-based The Medicines Co has sued Aurobindo Pharma after claims the Indian pharmaceutical company infringed two patents related to its heart drug Angiomax (bivalirudin).
The lawsuit, filed at the US District Court for the District of New Jersey, on April 11, was filed in response to Aurobindo’s application to market a generic version of the drug.
The Medicines Co has asserted two patents in the lawsuit, US numbers 7,582,727 and 7,598,343.
The New Jersey-based company says Aurobindo filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for approval to make a generic version of the drug without reasonable basis that it would infringe the patents.
The ‘727 and ‘343 patents, which cover pharmaceutical formulations of bivalirudin and processes of making the drug, will expire in July 2028. In its complaint, The Medicines Co said that it is entitled to a six-month period of exclusivity following the patents’ expiration.
Angiomax prevents the formation of blood clots during angioplasty. The drug registered sales of $608.6 million last year, which accounted for around 88 percent of Aurobindo’s net revenue.
The Medicines Co is seeking a judgment that the ANDA was an act of infringement and that any commercial sale or manufacturer would amount to infringement.
It adds that a generic should be given approval before the patents have expired in 2028. It is also seeking damages and attorney’s fees.
Aurobindo did not respond to immediate requests for comment.
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Angiomax, Aurobindo Pharma, The Medicines Co, FDA, ANDA, Generic