Allergan v. Valeant pharmaceuticals @XIFAXAN 550 mg ANDA

As days goes on, the problems for Valeant Pharms were keep on increasing, wherein the company, already had a major down fall at stock market and now the company stated that it has received a Paragraph IV Notification for Xifaxan.

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On February 23, 2016, FDA has announced that it has received an Abbreviated New Drug Application (ANDA) containing a “Paragraph IV” patent certification to market a generic copy of XIFAXAN 550mg.

Allergan announced that the Company has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) seeking approval to market Rifaximin Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

Valeant Pharma’s Patent portfolio

As it is already known that Valeant has adopted a policy of aggressive acquisitions, which have resulted in its sales growth. The company got complete rights over Salix Xifaxan after it acquired Salix Pharms.

On Mar 24, 2010 Salix received FDA approval for its XIFAXAN 550 mg, several exclusivities such as NP and ODE were granted by FDA for this product.

Currently , there are several patents listed in Orange Book for XIFAXAN 550 mg which are all set to expire in between 2019-2029.

Valeant have several key products in its product portfolio such as Jublia (efinaconazole) and Xifaxan (rifaximin) etc.,

As of date there are no patent infringement filed by Valeant under 35 USC § 271(e)(2) against the Allergan (Actavis), the due date for initiating patent infringement seems to be end by April 13, 2016.

In 2014 Valeant failed to acquire Allergan, which was later acquired by Actavis.

For the 12 months ending December 31, 2015, XIFAXAN® 550 mg had total U.S. sales of approximately $975 million.

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