Barr Pharma has initiated a challenge of the Orange Book listed patents byAzur Pharma w.r.t FazaClo(R) (clozapine) orally disintegrating tablets, 25mg and 100mg. Following patents are listed for this product:
US5178878 (Expiry: Jan 12, 2010): which covers a solid pharmaceutical dosage form adapted for direct oral administration to a human comprising: a mixture of at least one saliva activated effervescent agent and a plurality of microparticles, each said microparticle including at least one systemically distributable pharmaceutical ingredient and a protective material substantially encompassing said pharmaceutical ingredient, said microparticles having at least about 70 percent 30-minute release, said mixture being present as a tablet of a size and shape adapted for direct oral administration to a human patient, said tablet being substantially completely disintegrable so as to release said microparticles upon exposure to saliva, said at least one effervescent agent being present in an amount which is effective to aid in rapid disintegration of said tablet, without chewing, and thereby release said microparticles.
US6024981 (Expiry: Apr 9, 2018): which covers a hard, compresed, rapidly dissolvable dosage form adapted for direct oral dosing comprising: an active ingredient and a matrix including a non-direct compression filter and a lubricant, said dosage form being adapted to rapidly dissolve in the mouth of a patient and thereby liberate said active ingredient, and having a friability of about 2% or less when tested according to the U.S.P., said dosage form having a hardness of at least about 15 Newtons.
US6106861 (Expiry: Dec 5, 2017): which covers a multiparticulate tablet disintegrating in the mouth in less than 40 seconds and comprising an excipient and an active ingredient in the form of microcrystals comprising a taste-making coating wherein the excipient comprises, with respect to the mass of the tablet, from 3 to 15% by weight of at least one disintegration agent selected from the group consisting of cross-linked polyvinylpyrrolidone and cross-linked carboxymethylcellulose and from 40 to 90% by weight of at least one soluble diluent agent with binding properties consisting of a polyol having less than 13 carbon atoms, said polyol being either in the directly compressible form which is composed of particles whose average diameter is from 100 to 500 micrometers or in the powder form which is composed of particles whose average diameter is less than 100 micrometers, said polyol being selected from the group consisting of mannitol, xylitol, sorbitol and maltitol, with the proviso that, when only one soluble diluent agent with binding properties is used, it is a polyol in the directly compressible form except sorbitol and, when at least two soluble diluent agents with binding properties are used, these are consisting of the same polyol, one part of which is in the directly compressible form while the other part is in powder form, the proportion of directly compressible polyol to powder polyol being from 99/1 to 50/50 and the coating of the microcrystals of active ingredient comprises at least one coating agent selected as a function of the physico-chemical characteristics of the active ingredient selected from the group consisting of polymethacrylates and cellulose polymers and combinations thereof with each other.
US6221392 (Expiry: Apr 9, 2018): which covers a hard, compressed, rapidly dissolvable dosage form adapted for direct oral dosing comprising: an active ingredient and a matrix including a nondirect compression filler and a lubricant, said dosage form being adapted to rapidly dissolve in the mouth of a patient and thereby liberate said active ingredient, and having a friability of about 2% or less when tested according to the U.S.P.
The Barr pharma has designed around the said formulation patents. Also, Barr will be entitled for first to file 180 days exclusivity on this product.
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