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In two separate filings in the US district court of North Carolina, Apotex has pointed to Ranbaxys troubles with the US Food and? Thats because 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 a 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! Ranbaxy is also first in line to launch the other drug in question. If Apotex wins the cases, Ranbaxys 180-day exclusivity period for the first drug will begin immediately, regardless of whether or? And it will also lose its position at the head of the queue to launch the other drug. Following the settlement with GlaxoSmithKline lc. (GSK) in 2007, Ranbaxy won a 180-day marketing exclusivity for the herpes drug and said it expected 2310847 launch this by the end? Apotex cannot launch its own generic version till this period expires, said the Canadian firms filing.

It added that it believes that FDAs action against Ranbaxy would prevent it from commercially marketing a generic valacyclovir (the name of the active ingredient! The companys filing also claimed that Ranbaxy makes valacyclovir at its Dewas facility, which is under FDAs scanner. On 16 September 2008, FDA had issued warning letters to Ranbaxys manufacturing plants at aonta Sahib in Himachal radesh and Dewas. Valtrex has annual sales of $1. 3 billion (Rs6,360 crore). According to Zoloft for dogs Ranbaxy was expected to make $150-200 million from the launch of its generic version of Valtrex.
Apotex didnt respond to emailed queries although Mint has copies of the two court filings made on 1 and 7 July. Ranbaxys spokesperson declined comment. This risk that exclusivity could be triggered early is not limited to the two products in question, but also applies to other products such as Nexium and Lipitor where other companies have applied for declaratory. Apotex is trying to Wellbutrin and beer Ranbaxys exclusivity early and pave the way for its own launch (for the products).

We believe the risk is lower for filings from Dewas than those from aonta because of the AI invoked on the latter, said rashant Nair, analyst with Citi Investment Research. AI refers to the application integrity policy that FDA invoked on a company or a manufacturing plant of a company and simply means that the regulator will? In April, during a conference call with analysts after the announcements of its results for the first quarter of 2009 (Ranbaxy! There is a clear possibility it (Valtrex) can be launched, he had said.

Singh resigned from the company in 24 May. Earlier, in June 2008, Singh and his family had sold their entire 34. 8% stake in Ranbaxy to Japans Daiichi Sankyo Co... At that time, it had been announced that Singh would stay on at the company till 2013... Last year, Ranbaxy failed to launch the generic version of GSKs Imitrex for which it had a 180-day ARE ULTRAM AND TRAMADOL THE SAME

Its loss was Dr Reddys Laboratories Ltds gain. The firm launched its authorized generic version of the drug in November and admitted in March that this was behind its higher gross profit margins. In the case of Aricept, Apotexs filing said that a reasonable opportunity for further investigation and discovery will show Ranbaxys tentative approval has been revoked because Ranbaxy failed to comply or conform with. Ranbaxy will not be able to enter the market for generic donepezil hydrochloride (the active ingredient of Aricept) on November 25, 2010 without final approval...

Generic entry will be delayed indefinitely if Ranbaxy does not launch on November 25, 2010, the filing adds. Shares of Ranbaxy closed 2% down at Rs248. 20 each on the Bombay Stock Exchange on a day when Sensex fell 2...

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