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Lupin is on track as far as its pipeline of generic drugs is concerned. As estimated, the company on Friday announced the launch of its generic version of cholesterol-control drug Niacin in the US. The drug is estimated to have annual sales of $1 billion. Lupin said on Friday it had got the necessary approvals from the US Food and Drug Administration (FDA) to launch Niacin Extended-Release Tablets USP in 500 mg, 750 mg and 1,000 mg strengths.
Abbvie is the patent holder for this drug, which expired in September last year. However, a generic version of this drug has been in existence since 2005. Barr Pharmaceuticals got US FDA approval in 2005 to launch the generic version of this drug.
Due to this, not many analysts are enthused about Lupin’s drug launch. Ranjit Kapadia, pharmaceutical analyst at Centrum believes, Lupin might derive $15-20 million in sales annually from this drug, as the market will be split between at least three generic companies. Also, the generic version of this drug has been in existence since 2005.
Though Niacin is a $1-billion drug, with the launch of generics its price could fall 95 per cent and the three generic companies may capture the market for this drug, after March. Sun Pharma is also expected to get approval for the same drug soon.
Nomura, in a note in December last year, had indicated Lupin could possibly face limited competition in the first 100 days of its launch, before other generic players entered the market.
However, not many believe this theory. In the note, Nomura said Lupin’s US launches presented upside risks to consensus estimates. It said: “We believe LPC has one of the best US generic pipelines among India players that can present sustained growth in three years. The company has a healthy pending/approved abbreviated new drug application (ANDA) ratio of 1.26 (March 13). LPC’s revenue per ANDA approved at $7 million is the highest among Indian peers, indicating LPC’s ability to identity and execute on the right product opportunities.”
