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Paxil – What a Shock! Another Generic Fight

By September 24, 2010July 9th, 2019Uncategorized

A short time ago, the pharma company Mylan was given an exclusive arrangement to sell a generic formulation of Glaxo Smith Kline’s antidepressant Paxil CR. These arrangements typically last 180 days when granted, and are meant to prevent oversaturation of the market and mayhem caused by unregulated competition. Now, Mylan has leveled a suit against Glaxo, claiming that the pharma giant is allowing another company — Apotex Inc. — to manufacture another generic version of Paxil CR.

The basis of the case is, of course, largely economic. Mylan is arguing that allowing Apotex to produce an “authorized” version of Paxil CR would drastically undercut Mylan’s market share and destabilize the market in general. Further, Mylan officials contend that Glaxo has breached a 2007 agreement between it and Mylan which granted Mylan exclusivity to sell the generic form of the drug before the patent’s expiration in 2016. The courts have, for the moment, agreed with Mylan, issuing an order blocking Apotex from going forward with production or sale of the antidepressant.

This all might seem a bit dense and obscure to the average patient. This is because none of these discussions is taking place with the eventual patient in mind. The arguments in such cases are solely for financial concerns, with companies attempting to protect their perceived turf against encroachments from other companies.

None of the documents in this case for example brings up or even is affected by the ongoing litigation related to the safety of SSRIs such as Paxil CR. While people still are calling attention to the increased rate of birth defects in children whose mothers took Paxil while pregnant, as well as to the increased rate of suicidal thoughts and attempts in patients taking Paxil at a young age, companies are busy fighting out who gets to market the cheap, generic versions of the drug that will be put on the market with the same effects and risks as the parent drug.