Journal of Generic Medicines

TABLE 1

FROM:

Fluvastatin and Atorvastatin: A comparison of patent protection (Part 2)

Leighton Howard

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Table 1. (a) Atorvastatin key patents and (b) Fluvastatin key patents

ApplicantPriority applicationClaims coverage
(a)
Warner LambertUS-1986-0868867 30/05/1986Atorvastatin active ingredient — generic formula (racemate).
Warner LambertUS-1989-0384187 21/07/1989Atorvastatin active ingredient — specific formula (enantiomer) and hemicalcium salt thereof.
SandozUS-1991-0805667 12/12/1991Formulation of a statin comprising an alkaline medium capable of imparting a pH of 8 or higher to an aqueous solution or dispersion of the composition.
Warner LambertUS-1993-0005708 19/01/1993Stable, oral formulation comprising Atorvastatin hemicalcium salt and a metal salt additive.
Warner LambertUS-1995-0001452 17/07/1995Crystalline Forms I, II and IV of Atorvastatin and hydrates.
PfizerEP-1998-0936587 11/08/1998Combination of Atorvastatin and Amlodipine for treatment of hypertension and hyperlipidemia.
   
(b)
SandozUS-1982-0443668 22/11/1982Fluvastatin active ingredient.
SandozUS-1991-0805667 12/12/1991Formulation of a statin comprising an alkaline medium capable of imparting a pH of 8 or higher to an aqueous solution or dispersion of the composition.
Astra (reassigned to Novartis)SE-1996-0003667 08/10/1996Pharmaceutical composition for sustained release comprising a water-soluble salt of Fluvastatin in a matrix formulation, or diffusion-controlled membrane coated formulation.
NovartisUS-2000-0549222 13/04/2000Sustained-release tablet containing granules of <200 microns that comprise Fluvastatin and a hydroxypropyl methyl cellulose polymer.
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