Lupin moves US FDA to block cefixime (Suprax) oral suspension generics from rivals including Orchid Pharma

India’ Lupin has approached the US Food & Drug Administration (US FDA) asking not to approve generic versions of antibiotic cefixime in oral suspension from companies including Orchid Pharma unless their products meet “the same standards that the Lupin drug had to meet”, reports said.

Lupin currently has generic cefixime in oral suspension in the US market which is expected to contribute nearly 8% of its sales revenue.

Cefixime was sold under the trade name Suprax in the USA, until 2003 when it was taken off the market by drug manufacturer Wyeth after its patent expired. Lupin then re-launched Suprax in US market.

Cefixime currently is an off-patent antibiotic, open to generic makers to copy and make their own versions.

Several companies including India’s Orichid Pharma has already filed abbreviated new drug applications (ANDA) with US FDA under Para IV seeking approval for marketing generic cefexime oral suspensions in the US market.

While the Chennai, south India based Orchid Pharma expects to launch its version cefixime oral suspension generic by next year, others like Delhi-based Nectar Lifesciences are planning to file ANDAs for the antibiotic.

Lupin’s Cefixime registered gross sales of $74 million (Rs 350 crore) in the financial year 2008-09, Lupin said.

Lupin Pharmaceuticals, Inc has got an exclusive trademark license by the innovator for marketing Suprax in the US.

After obtaining a product licence from Fujisawa in 2003-04, Lupin launched several variants of cefixime in the US market to control the sales of the antibiotic.

Now with generic competition in sight, Lupin has sought US FDA to approve the generic versions of rival companies only if their cefixime oral suspensions meet the same rigorous standards Lupin’s Suprax has to undergo to secure an approval.

Lupin had to meet very stringent requirements to get the FDA approval and wants to ensure that all ot­her applicants meet the­se same requirements, Lupin officials are quoted as saying.

Cefixime is an oral third generation cephalosporin family of antibiotics. The cephalosporin antibiotics family includes cephalexin (Keflex), cefaclor (Ceclor), cefuroxime (Zinacef), cefpodoxime (Vantin), cefprozil (Cefzil), and many injectable forms.

Cefixime stops bacteria from multiplying by preventing bacteria from forming the walls that surround them. The walls are necessary to protect bacteria from their environment and to keep the contents of the bacterial cell together; bacteria cannot survive without a cell wall.

Cefixime is active against a very wide spectrum of bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (the cause of strep throat), Hemophilus influenzae, Moraxella catarrhalis, E. coli, Klebsiella, Proteus mirabilis, Salmonella, Shigella, and Neisseria gonorrhoeae.

Cefixime got US FDA approval in April 1989. Cefixime is used to treat gonorrhea,tonsilitis, and pharyngitis.