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Tuesday, July 30, 2013 11:08:45 AM
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
'146 claims: A pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA and where less than 5%, and preferably less than 3%, is in the form of DHA is provided.
The invention claimed is:
1. A pharmaceutical composition comprising one or more fatty acids, at least 95% of which are in the form of ethyl-eicosapentaenoic acid, wherein the composition contains no docosahexaenoic acid and the composition is present in a capsule.
2. The composition of claim 1 wherein the composition contains less than 3% of any fatty acid other than eicosapentaenoic acid.
3. The composition of claim 2 wherein the capsule is a gelatin capsule.
4. The composition of any one of claim 1, 2, or 3 wherein the ethyl-eicosapentaenoic acid is present in the composition in an amount of 250 mg to 1000 mg.
5. A pharmaceutical composition comprising 250 mg to 1000 mg of fatty acids at least 95% of which are in the form of ethyl eicosapentaenoic acid, wherein the composition contains no docosahexaenoic acid, and the composition is present in a capsule.
6. A pharmaceutical composition comprising 250 mg to 1000 mg of fatty acids at least 95% of which are in the form of ethyl-eicosapentaenoic acid, wherein the composition contains (a) less than 5% in aggregate of arachidonic acid and n-3 docosapentaenoic acid, and (b) no docosahexaenoic acid; and wherein the composition is present in a capsule.
7. The pharmaceutical composition of claim 5 wherein the composition contains arachidonic acid in an amount less than 3%, by weight, of said fatty acids.
8. The pharmaceutical composition of claim 6 wherein the composition contains docosapentaenoic acid in an amount less than 3%, by weight, of said fatty acids.
9. The pharmaceutical composition of claim 6 wherein the composition contains arachidonic acid and docosapentaenoic acid in an aggregate amount of less than 3%, by weight, of said fatty acids.
10. The pharmaceutical composition of claim 6 wherein the capsule comprises about 1000 mg of said composition.
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Very important points AZN:
1) Amarin has it in the OB, "Fatty Acid"
2) Claim #8 shoots your Omthera Patent app #13734846 DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM
I was slightly concerned you might have got that one through, until today. Epanova's got a snowballs-in-hell for getting IP or NCE. If it makes it beyond the 74 day letter, which I doubt due to Lovaza RLD.
What a waste of $260 Million!
Biobill
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