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McNeil's Haldol

Executive Summary

Company submits additional comments March 27 to a petition seeking five-year marketing exclusivity for Haldol (haloperidol decanoate) under the Patent Term Restoration Act. Citing a recent federal court decision involving Glaxo and the Patent Office, McNeil asserts that the ruling "supports the position that the term 'active moiety' cannot be used as equivalent to 'active ingredient' as defined in the Act." The company says that the product qualifies for exclusivity because haloperidol decanoate is the "active ingredient" of Haldol even though the drug is converted in vivo into haloperidol, an already approved drug.
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PS015390

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