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Re: Biobillionair post# 6834

Wednesday, 05/22/2013 7:10:44 AM

Wednesday, May 22, 2013 7:10:44 AM

Post# of 426184
Two very important points:
1)"fixed or non-fixed dose"
2)"Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent."

The patent wasn't watered down, it was modified to pass quickly, and ambiguous fixed or non-fixed dose to get OB'd. Very smart. Stronger wording will likely get approved later this year, but may not be able to get OB'd because currently Amarin doesn't have an approved combo.

Williams

"Through our findings from conversations with thought leaders and other clinicians during the launch of Vascepa, we've confirmed that many patients on therapies intended for lowering triglycerides are also on statins. The claims in this allowed application cover the administration of a pharmaceutical composition comprised of EPA in conjunction with a stain, using either a fixed or non-fixed dose, to lower triglycerides without increasing LDL-C, otherwise known as bad-cholesterol," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent.
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