New Delhi: Drug maker Ranbaxy Laboratories Ltd is unlikely to get the US drug regulator’s approval for its generic version of GlaxoSmithKline Plc.’s (GSK’s) anti-migraine medicine Imitrex soon enough to benefit from the 180-day sales exclusivity period it has been granted for the drug, because the application was filed from its banned Dewas facility in Madhya Pradesh, according to analysts.
The company could lose out on Rs120-250 crore in revenue if it can’t take advantage of the exclusive period, the analysts said.
After settling a patent litigation with GSK last January, Ranbaxy had planned to launch 25mg, 50mg and 100mg strengths of sumatriptan, the generic version of Imitrex, in December.
As the first to file a so-called abbreviated new drug application (ANDA), Ranbaxy was awarded the 180-day exclusive sales right in the US under the Food and Drug Administration’s (FDA) rules.
Opportunity lost: Ranbaxy’s Malvinder Mohan Singh. The firm could lose out on Rs250 crore if it can’t take advantage of the 180-day period. Ramesh Pathania/Mint
An ANDA is an application for a generic drug.
A Ranbaxy spokesperson refused comment on the point of origin of the ANDA filing, and would only say that the company is awaiting approval from FDA for the launch of sumatriptan and is on track for the launch of antiviral drug valacyclovir—Valtrex—in 2009.
In an email response to Mint, FDA spokesperson Christopher Kelly said: “The import alert is still in effect and because this is an open investigation, FDA has no further comment at this time.”
The Imitrex opportunity came under a cloud in September when FDA issued an import alert on drugs from Ranbaxy’s Dewas and Paonta Sahib (Himachal Pradesh) plants. Ranbaxy sources the active pharmaceutical ingredient for the drug from Hyderabad-based SMS Pharmaceuticals Ltd.
“Given that the Paonta Sahib facility has been under the scanner for over two years (with no new products being approved), the company started filing...ANDAs from the US facilities,” wrote Prashant Nair, analyst, Citigroup Investment Research, in a note to investors soon after the FDA import alert. “The inclusion of the Dewas facility in the...ban was a surprise.”
This may have left Ranbaxy with little legroom to shift its filing for Imitrex from Dewas to another facility in time for a December launch. “We specifically mentioned (in that note) that the ANDA (for Imitrex) may have been filed from one of the (FDA) affected sites. Imitrex will be a one-time loss for Ranbaxy but will not affect the company on a per share basis,” Nair said.
Rajesh Vora, an analyst with ICICI Securities Ltd, wrote in a December note, “...since the product (Imitrex) is filed from one of the two plants (Dewas/Paonta Sahib) under the US FDA’s scanner and has not received final approval (tentative approval was received in July 2005), Ranbaxy has not been able to launch the product yet, and may not be able to do so within the 180-day exclusivity period.”
Vora predicts an opportunity loss of $20-25 million (Rs97.2-121.5 crore).
“Ranbaxy was trying to move the Imitrex filing from Dewas to their facility, Ohm Laboratories, in the US but even that takes a few months,” said another analyst who spoke on condition of anonymity. “Even if they would have managed to file a new ANDA from Ohm in October 2008, there is no chance they would get approval before April 2009. The FDA can take 6-18 months to approve a new ANDA. The Imitrex opportunity is over.”
GSK’s patent for Imitrex, which clocks $1 billion in annual sales, expires in February.
While Dr Reddy’s Laboratories Ltd got approval to launch the authorized generic version of Imitrex in November, after a patent litigation settlement with GSK, eight other companies have already received tentative approvals from FDA to launch generic versions of the drug after its patent expiry.
“Ranbaxy informed us that it would shift the Imitrex filing from Dewas to Ohm Laboratories, but that is a long-drawn process and an ANDA approval can take many months,” said Ranjit Kapadia, head of research, private client group, at brokerage Prabhudas Lilladher Pvt. Ltd. He sees potential revenue losses of up to Rs250 crore for Ranbaxy from launching the drug after the exclusive period.
Analysts expect Ranbaxy’s issue with FDA to get resolved by December, but admit to earlier incidents where such investigations have lasted for as long as five years.