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News Breaks | | | | January 4, 2013 | | 06:56 EDT |  | SCMP | Sucampo receives Paragraph IV certification notice letter on ANDA by Anchen
Sucampo Pharmaceuticals says in a filing that on January 2, it received a Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Anchen Pharmaceuticals requesting approval to market, sell and use a generic version of the company’s 8mcg and 24 mcg AMITIZA products. In its Notice Letter, Anchen alleges that U.S. Patent Nos. 6,414,016, 6,583,174, 7,064,148, 7,417,067, 7,795,312, 8,026,393, 8,071,613, 8,088,934, 8,097,649, 8,097,653, and 8,114,890, which cover composition, formulations and methods of using AMITIZA, are invalid, unenforceable and/or will not be infringed by Anchen’s manufacture, use or sale of the products described in its ANDA. The latest of the Patents expire in 2027. The company is currently reviewing the Notice Letter. By statute, if the company initiates a patent infringement lawsuit against Anchen within 45 days of the Notice Date, then the FDA would automatically stay approval of Anchen’s ANDA until the earlier of 30 months from the Notice Date or entry of a district court decision finding the Patents invalid or not infringed. The company intends to vigorously enforce its intellectual property. | |
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News For SCMP From The Last 14 Days Check below for free stories on SCMP the last two weeks. |
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| May 17, 2013 | | 10:36 EDT |  | SCMP | Leerink's major/specialty pharma analyst holds analyst/Industry conference call
 Subscribe for More Information | | | May 13, 2013 | | 15:31 EDT | | SCMP | Sucampo to hold a pharmaceutical update meeting
Pharmaceutical update to discuss the recent opioid-inducted constipation (OIC) indication approval for Sucampo's Amitiza is being held in Orlando, Florida on May 20 at 9 am. Webcast Link | | | May 7, 2013 | | 17:57 EDT | | SCMP | Sucampo expects to recognize $10M milestone payment for Amitiza in Q2
The payment is from Takeda Pharmaceutical (TKPYY). | | | 16:28 EDT |  | SCMP | Sucampo reports Q1 EPS with items(8c), consensus (8c)
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