Aurobindo’s ANDA to be examined.
By Deepak Chitnis
WASHINGTON, DC: Yet another Indian pharmaceutical company has found itself in the crosshairs of the US regulators. This time, three separate US drug companies have fingered Hyderabad-based Aurobindo Pharma under allegations of patent infringement.
Hospira, Kowa Co. Ltd., and The Medicines C. have each filed a lawsuit against Aurobindo because of the latter’s new Abbreviated New Drug Application (ANDA), which they each say infringes on a patent for a drug that they produce. According to the suits, Aurobindo’s ANDA will be used to make a generic version of a dexmedetomidine hydrochloride injection.
Hospira alleges that such a drug would be a copy of its Precedex drug. Kowa says that the Aurobindo drug would be a copy of its Livalo (Pitavastatin) medication, and Medicines Co. has said that it the new drug would infringe upon its Angiomax (bivalirudin) patents.
Hospira has filed its case with the US District Court of Delaware; Kowa has taken its lawsuit to the District Court for the Southern District of New York (the territory of Indian American legislator Preet Bharara), and Medicines Co. has filed their suit with the District Court of New Jersey.
The ANDA has been filed with the US Food and Drug Administration (FDA). If the FDA grants the application, it will allow Aurobindo to produce the dexmedetomidine hydrochloride injection drug, which the other three companies clearly don’t want to happen. They are each seeking an injunction against production of the drug.
Aurobindo stock dipped slightly on Tuesday, in response to the trio of lawsuits, but a company spokesperson told the Hindu Business Line that litigation regarding generic drugs is commonplace, and that it was not something that the company was overly concerned about.
Founded in 1986, Aurobindo Pharma specializes in the manufacturing of generic drugs, particularly in the therapeutic sector. It is one of the larger drug companies in India, and earlier this year, purchased fellow drug company Actavis, which is based in Ireland and New Jersey.