The Hindu Business Line : Lupin forays into branded generics in US

Armed with the regulatory approval for antibiotic Cefixime in the suspension form — Lupin is poised to re-launch the product in the US under the Suprax brand, thus marking its entry into the branded generic market in the US.

Lupin's predecessors, in this regard, include Ranbaxy Laboratories Ltd and Dr Reddy's Laboratories Ltd.

"The long-awaited approval for Cefixime in the suspension form is significant for Lupin, since it marks the company's entry in the branded finished products market in the US. Till now, the company was into selling drugs based on different delivery systems," said Ms Vinita Gupta, Lupin's President for North America and Europe.

Speaking to mediapersons from Baltimore, she said, Lupin had licensed the trademark from Wyeth, which had been marketing the drug till March 2003.

On Lupin giving a fresh lease of life to a product that had been discontinued, Ms Gupta told Business Line: "Wyeth discontinued because it did not fit its product portfolio. We took it on, since our research found the product sound on safety and efficacy. It was accepted by paediatricians, had a unique once-a-day dosage."

Analysts point out that even the Ranbaxy and DRL are finding the going tough in the branded drugs market and the fate would be quite the same for Lupin.

"Other companies have faced generic competition (onslaught from chemically equivalent drugs). The challenge is to get a molecule that the market wants and that has significant qualities over competition. Also, one should look at how to bring it to market, which is why we have a strong field-force. With little direct competition, Lupin hopes to get about 15-18 months exclusivity on Suprax," she said.

The original patent-holder for the drug is Fujisawa Pharmaceutical, which is set to merge its over-the-counter business with Yamanouchi Pharmaceutical in October 2004, analysts point out. But Fujisawa's status would have no bearing on Lupin's pact with Wyeth, she countered.

Lupin would have to pay a royalty to Wyeth for Suprax, but she was unwilling to divulge details.

Also, the trademark license agreement did not have a definite timeframe, she said.

Suprax is set for launch in the US by April, she said. Lupin would push the product aggressively through a 500-strong field-force. With the segment seeing more molecules from competitors such as GlaxoSmithKline's antibiotic Augmentin and its generic versions - Lupin is looking to recover ground in its first year of operations. Suprax under Lupin looks to garner sales of about $51 million, the amount Wyeth had clocked when it exited the product.

Suprax will be sold under the Lupin label and once the company gets its act right, it would look at more branded drugs in about 12 months, she said.

Lupin's strategy would be to build its branded drugs base in the US and leverage this for the European market.

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