Sunday, March 18, 2007


Ranbaxy in the US market


Rupali Mukherjee

Pharma major Ranbaxy Laboratories is expected to mop up nearly $2 billion in sales by launching generic versions of four block-buster drugs, including atorvastatin (Lipitor) over the next five-six years.

The block-buster molecules including atorvastatin (lipitor), pioglitazone (actos), valacyclovir (valtrex) and tamsulosin (flomax), are expected to be launched in US during 2007-2012, subject to the requisite legal and regulatory approvals.

At present, the company has 20 First-to-File (FTF) products that command a market size of over $26 billion (at innovator brand prices) with nine under litigation. The first-to-file status is granted to the first generic company which files the abbreviated new drug application (ANDA) with a Para IV certification. The first-to-file benefit allows 180 days of exclusivity in the US market to the company.

Ranbaxy CEO and MD, Malvinder Singh said, "The potential first-to-file molecules present a sizeable opportunity, and offer significant commercial upside to our organic growth plans". The company has filed 197 ANDAs with the US FDA, of which 121 have been approved, while 76 are pending. Cumulative value of 76 pending ANDAs is valued around $50 billion (at innovator brand prices).

Domestic generic companies like Ranbaxy and Dr Reddy's have become aggressive in challenging blockbuster drugs from MNCs through Para IV filing of their ANDAs in the US and Europe. They are eyeing huge revenues which they can earn from the 180-day market exclusivity.

Singh added: Our strategy on litigations is a considered one where we bring to bear our innovative R&D capabilities to develop generic alternative and litigate against patents which are weak in our opinion. We challenge them based on the fact that we believe, after due consideration and careful study, that they are invalid or not infringed.

Ranbaxy has developed a robust product flow, and plans to launch new products with a focus on products comprising vanilla generics, niche/value-added products, complex technology products & first to file (Para IV) products. US is the most important market for the drug major, and contributed $380 million to the total global sales of $1340 million in 2006.

Analysts say that the company is expected to launch one first-to-file product every year, with the first one to be launched next year. Last year, the company launched simvastatin tablets (80mg) with a 180-day exclusivity in the US. The product has garnered over 50% share of the generics market and notched up around $70 million in sales.

Recently, Ranbaxy has got involved in a litigation against Pfizer to launch the generic version of cholesterol and blood pressure medicine, Caduet. Pfizer has filed a complaint in the federal court in Delaware, saying that the copy would infringe patents that expire in 2010. Sales of the Caduet totalled $325 million last year.

In another example, through its challenge of Pfizers patent on cholestrol lowering drug, Lipitor, Ranbaxy has been able to bring forward the launch of the generic version by 15 months with 180 days exclusivity in US . Analysts say that an estimated $70 billion worth of branded products are expected to go off-patent between 2007-11.

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