Guaifenesin / Guaifenesin & Pseudoephedrine – USA

Guaifenesin / Guaifenesin & Pseudoephedrine – USA

On Aug. 22, 2017, United States District Court for the District of New Jersey issued an opinion ruling that Amneal Pharmaceuticals & DR Reddy’s did not infringe patents owned by Reckitt Benckiser by seeking permission from FDA to market a generic version of Mucinex® & Mucinex®D before the expiration of orange book patents.
Reckitt Benckiser holds an approved New Drug Application (“NDA”) for Mucinex® (Guaifenesin)& Mucinex®D (Guaifenesin & Pseudoephedrine) extended-release tablets.  Mucinex®& Mucinex®D were approved by the United States Food and Drug Administration (“FDA”) in Jul 12, 2002 & Jun 22, 2004 respectively. There are total 03 patents listed in orange book (OB) expiring on Apr 28, 2020.
Amneal Pharmaceuticals filed Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Mucinex® & Dr Reddy’s filed ANDA for Mucinex®D.  Dr. Reddy’s Mucinex®D case was consolidated with Amneal. New Jersey District Court held bench trial on May 18, 2017 & ruled that Amneal and Dr Reddy’s did not infringe U.S. Patent Nos. 6,372,252; 6,955,821 and 7,838,032. 
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