BMS bags a patent for its HCV trial drug

BRISTOL-MYERS SQUIBB COMPANY has filed an Indian patent application IN 9336/DELNP/2008 claiming cyclopropyl fused indolobenzazepine compounds which covers Beclabuvir (BMS-791325) an antiviral drug for the treatment of hepatitis C virus (HCV) infection currently in clinical trials. Beclabuvir acts as a NS5B inhibitor.

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IN ‘9336 was entered in India through PCT/US2007/068209 (published as WO 2007/136982), a hearing was offered to applicant on January 22, 2016 regarding the objections raised by the examiner.

Applicant has made his observations / arguments and filed amended set of claims, the examiner was satisfied with respect to all the objections raised previously and allowed the application for grant containing 16 claims, as of now there is no patent number assigned for this application. The decision can be find here.

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.