Horizon Pharma (HZNP) Says Par Pharma (PRX) Files ANDA for Generic DUEXIS
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Horizon Pharma, Inc. (Nasdaq: HZNP), today announced that it had received a Paragraph IV Patent Certification from Par Pharmaceutical, Inc. (NYSE: PRX), advising that Par has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration ("FDA") for a generic version of DUEXIS, containing 800 mg of ibuprofen and 26.6 mg of famotidine. Par has not advised Horizon as to the timing or status of the FDA's review of its filing, or whether it has complied with FDA requirements for proving bioequivalence.
Horizon is evaluating the Paragraph IV certification and intends to vigorously enforce its intellectual property rights relating to DUEXIS. All of the issued U.S. patents covering DUEXIS are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA's rules and regulations, if Horizon initiates a patent infringement suit to defend the patents identified in the Paragraph IV notice within 45 days after its receipt of the notice, the FDA would be prevented from approving the ANDA until the earlier of 30 months or a decision in the infringement case that each of the patents are not infringed or invalid. In addition to the two issued U.S. patents listed in the Orange Book, Horizon is currently prosecuting additional patent applications that would cover DUEXIS.
Horizon is evaluating the Paragraph IV certification and intends to vigorously enforce its intellectual property rights relating to DUEXIS. All of the issued U.S. patents covering DUEXIS are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA's rules and regulations, if Horizon initiates a patent infringement suit to defend the patents identified in the Paragraph IV notice within 45 days after its receipt of the notice, the FDA would be prevented from approving the ANDA until the earlier of 30 months or a decision in the infringement case that each of the patents are not infringed or invalid. In addition to the two issued U.S. patents listed in the Orange Book, Horizon is currently prosecuting additional patent applications that would cover DUEXIS.
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