Jul

9

Ranbaxy in a soup again

Posted on: July 9, 2009 at 6:58 am | 4 views




Ranbaxy Laboratories, who has been facing problems with the US drug regulator, suffered a further blow, with Canadian generic or off-patent drug maker Apotex questioning in court the company`s ability to launch two generic drugs on schedule, reports Mint.

In two separate filings in the US district court of North Carolina, Apotex has pointed to Ranbaxy`s troubles with the US food and drug administration (FDA) and said that these may prevent the Indian firm from launching two big products—generics versions of herpes drug Valtrex and Alzheimer`s drug Aricept—and thereby hurt the business of other generic companies, including the Canadian firm`s.

Reason being the firms that get first permission to launch generic versions of drugs also get a so called marketing exclusivity period during which no other generic company will be allowed to launch its version. Ranbaxy has 180-day exclusivity for one of the two drugs and while this time is usually calculated from the date of launch of the generic version, the company`s troubles with FDA could mean a significant delay in the launch.

If Apotex wins the cases, Ranbaxy`s 180-day exclusivity period for the first drug will begin immediately, regardless of whether or not it has permission from FDA to market the drug also it will  lose its position at the head of the queue to launch the other drug.

Apotex added that it believes FDA`s action against Ranbaxy would prevent it from commercially marketing a generic valacyclovir (the name of the active ingredient in Valtrex) product for an indefinite period of time in the future. The company`s filing also claimed that Ranbaxy makes valacyclovir at its Dewas facility which is under FDA`s scanner.

It is further learnt that Apotex is trying to trigger Ranbaxy`s exclusivity early and pave the way for the launch of its own products.




Tags:, , , , , , , , , , , , , , , , , ,

Related Post :