Replies to post #238955 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

They do.

Pfizer has no leg to stand on regarding patent rights regarding formulation. Clearly they do on exclusivity rights but only regarding Troxyca. Pfizer has no exclusivity rights regarding Embeda whatsoever any longer to my knowledge.

FDA will provide 3-5 years of marketing exclusivity, depending on the type of approval. They will not approve another drug using that drug as an RLD until the exclusivity period is over. But beyond that, there is patent protection, which patent holders enforce in court of law. FDA exclusivity has expired for Embeda, but as a proper assignee of the patent, Pfizer could and likely will sue Elite in an effort to enforce the patent (expires 2027) to prevent generic Embeda. Elite will argue their generic Embeda is produced using separately patented procedures and methods.