An increasing number of multinational pharmaceutical giants are losing their battle against local drugmakers, armed with generic copies.

Roche, a Swiss giant known for Tamiflu, recently canceled its plan to release Tamiflu Suspension Powder 12 mg (ingredient: oseltamivir phosphate). The product had been approved by the health authorities, but the company did not launch it. However, Roche will keep the approval for Tamiflu Suspension Powder 6 mg.

“We did not launch the 12 mg product, so we don’t have any reason to maintain its approval. But we still have the approval for the 6 mg one,” said an official at Roche.

Observers said Roche did not need to maintain the approval for the 12 mg product because generic copies of Tamiflu poured into the market, following the expiration of Tamiflu’s patent. Moreover, the oseltamivir-based suspension powder market has been preempted by a local drugmaker, which is another reason for giving up the approval, they said.

Although Roche first received the approval for oseltamivir suspension powder in 2007, Hanmi Pharmaceutical launched a similar suspension powder with better taste and beat Roche. Other local drugmakers, including Kolon Pharma, Yuhan, Ahngook Pharm, Dong-A ST, and Samjin Pharmaceutical, also jumped into the market later.

Oseltamivir suspension powder can prevent newborns 2 weeks of age or older, or patients 1 year and older, from being infected with influenza A and B. Thus, the market size is relatively small.

Mitsubishi Tanabe Pharma also plans to withdraw Talion, the top-selling antihistaminic agent that sold 2.3 billion won ($2 million) in Korea last year. Dong-A ST was in charge of local sales, but it agreed to return the sales rights to the Japanese firm next month. The Japanese company does not have any plan to hand over the sales rights to another local drugmaker, either.

Behind the struggles of multinational firms are local drugmakers’ launches of generic copies. Korean pharmaceuticals are already eyeing on Talion, as its patent expires next month. Industry watchers said about 60 generic copies would be out on the shelves soon.

Dong-A ST is to produce generics using the same material that Mitsubishi Tanabe had used, which pushed the Japanese company to withdraw Talion, observers said.

Pfizer’s Celebrex, which is leading the COX-2 inhibitor market, saw its accumulated prescription sales in the three quarters this year standing at 24.32 billion won, down 17.3 percent from a year earlier. Among treatments for osteoarthritis, Pfizer’s Celebrex and AstraZeneca’s Vimovo were the only two to suffer a decline in sales.

Moreover, Pfizer lost its dominance in the erectile dysfunction treatment market, as its representative drug Viagra has proved to be no match for Hanmi Pharm’s generic copy “Palpal.” Palpal sold about 2.5 times more than Viagra this year, which is likely to change the epitome of erectile dysfunction treatment to Palpal from Viagra.

sjh@docdocdoc.co.kr

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