Lupin moves to block rival generics

Pharma major Lupin Ltd is all set to block its rivals from foraying into the US market to sell antibiotic cefixime in oral suspension form. The company has approached the US Food and Drug Administration (FDA) with a citizen’s petition (CP) asking the regulator to approve the generic form of Suprax (cefixime) by applying the same standards of evaluation as were applied while approving the Lupin’s generic version of the drug.

Lupin’s move, according to analysts, would block other companies from launching their generic versions in the US market. At least two Indian companies - the Chennai-based Orchid Chemicals and the Delhi-based Nectar Lifesciences - have been trying to launch their generic versions of Suprax in the US market.

Suprax is indicated to act against a wide range of bacteria including staphylococcus aureus, streptococcus pneumoniae, streptococcus pyogenes, hemophilus influenzae, moraxella catarrhalis, e. coli, klebsiella, proteus mirabilis, salmonella, shigella and neisseria gonorrhoeae.

Lupin is expecting its generic Suprax to contribute about 8% to its topline. Though the CP filed by Lupin may not be able to stall competition from accessing the market completely, analysts estimate that the competition might get delayed by 3-6 months.

In fact, a CP is a common Abbreviated New Drug Application (ANDA) blocking devise adopted by pharma companies. According to analysts, Lupin had to go through rigorous scrutiny by the FDA while it was trying to launch generic Suprax there. Now, it does not want the competition to have a cakewalk even as it is yet to completely monetise the opportunity offered to it.

Cefixime was first sold under Suprax brand by Wyeth till 2003. However, after expiry of the patent that year the company took the drug off the market, following which Lupin started selling its generic version.

Though Lupin is one of the key players in the segment and had a revenue of about Rs 350 crore from the drug in 2008-09, cefixime is an off-patent drug and is open to other pharma companies to take their versions, too, to the market.

“Lupin had to go through a stringent verification process before launching its Suprax variants. Now, it is natural in this business to seek the regulator’s intervention to make others too to follow the same scrutiny. Though nothing significant would happen to other players if the FDA decides to oblige the application filed by Lupin, competition would only get deferred,” an analyst said.

As an antibiotic, cefixime prevents the formation of cell walls of bacteria thereby making it difficult for the bacteria to protect itself.