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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