There are safety issues with immediate-release niacin that would be magnified in a statin combo. So I don't see the OTC niacin as much of a threat, particularly if they had an effective sales force. It's on just about every formulary (lot cheaper than statins...), and so there isn't much incentive for people to go with an OTC product. It probably does serve to put a cap on their pricing though. (It's real cheap as drugs go).
They do have some minor patent protection:
Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) announced today that it has received a method-of-use patent (U.S. # 6,080,428) for the once-at-night dosing of niacin to safely treat cholesterol disorders. A second niacin patent, covering the dosing regimen and additional safety and formulation claims, also has been allowed and is expected to issue shortly. These two patents reserve for Kos, until 2017, the use of niacin administered once daily at night for cholesterol therapy, whether alone or in combination with other compounds, effectively creating an exclusive franchise both for the Company's currently marketed Niaspan(R) product and for its next-generation product, Nicostatin(TM).
Anyone want a patent for lunchtime dosing? <g>
Peter |
