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March 18, 2014
17:16 EDTPRX, HPTXHyperion says Par filed ANDA with FDA for generic version of RAVICTI
In a filing, the company said, "On March 10, Hyperion Therapeutics (HPTX) disclosed that it had become aware that the FDA on March 6, posted on its website that FDA’s Office of Generic Drugs had received an Abbreviated New Drug Application, ANDA, containing a Paragraph IV patent certification with respect to RAVICTI, glycerol phenylbutyrate, oral liquid on November 19, but that the company had not received notification of the Paragraph IV certification with respect to this filing. On March 17, the company received notification of the Paragraph IV certification from Par Pharmaceutical (PRX) advising the company that it had filed an ANDA with the FDA for a generic version of 1.1 gm/ml RAVICTI oral liquid. The Paragraph IV certification alleges that the company’s U.S. Patent No. 8,404,215, titled “Methods of therapeutic monitoring of nitrogen scavenging drugs,” which expires in March 2032, and U.S. Patent No. 8,642,012, titled “Methods of treatment using ammonia scavenging drugs,” which expires in September 2030, are invalid and/or will not be infringed by Par’s manufacture, use or sale of the product for which the ANDA was submitted. Par did not challenge the validity, enforceablility, or infringement of the company’s U.S. Patent No. 5,968,979, titled “Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders,” which expires in February 2015. The company intends to vigorously enforce its intellectual property rights relating to RAVICTI. As noted in the Initial Form 8-K, the Paragraph IV certification does not challenge or affect RAVICTI’s orphan drug exclusivity, which extends to February 2020."
News For HPTX;PRX From The Last 14 Days
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November 20, 2014
07:42 EDTPRXIntellipharmaceutics notes launch of 5mg strength Focalin XR by Teva
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November 12, 2014
08:23 EDTHPTXHyperion Therapeutics price target lowered to $32 from $38 at Cantor
Cantor cut its price target on Hyperion after the company reported stronger than expected Q3 results but said distributors would work down 10-12 days of inventory in Q4. The company also said that it would spend $7M-$10M on terminating its DiaPep277 program, noted the firm, which keeps a Buy rating on Hyperion.
07:53 EDTHPTXLeerink to hold a tour
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