Malaya – May 9, 2007

BY Irma Isip

BEFORE the year ends, it will be a wide open market for two best-selling hypertension and cholesterol busting drugs that generate sales of P2.5 billion a year.

Pfizer’s patent on Norvasc (generic name: amlodipine besylate) will expire on June 13. Norvasc sales were placed at P1.5 billion yearly.

The patent for another Pfizer drug, Lipitor, used in controlling blood fat or cholesterol, will also expire by year-end. "Lipitor" sales were estimated at P1 billion a year.

This early 10 local manufacturers of generic medicines are ready to make the drugs once they become off-patent.

At present, pharmaceutical giant United Laboratories makes Amvasc which has the same active ingredient amlodipine but with another binding agent.

Unilab’s Amvasc sells for P17.50 per 5 mg, 60 percent cheaper than Pfizer’s Norvasc.

Pfizer tries to compete by giving discounts through cardiologists who prescribe its product. The 50 percent discount, however, is available only at Mercury drugstores.

Here’s how it works. Norvasc 10 mg sells for P74.57. With the 50 percent discount, the retail price is cut to P37.25. When halved, the 10 mg tablet gives two doses at P18.60 each, for a competitive price to Unilab’s Amvasc at P17.50.

The discount card, however, is only good for 30 tablets per month per patient.

What makes the government sore, however is that in Thailand, Norvasc 5 mg is sold at P25 and in Pakistan, at P8.74.

The Philippine International Trading Corp. (PITC) which imports cheap medicines from India yesterday filed before the Intellectual Property Office of the Philippines (IP Philippines) an application for the cancellation of the patent of Pfizer on amlodipine besylate.

PITC executive vice president Teddie Rivera said the agency is also looking at registering Lipitor (atorvastatin calcium) to pave the way for the manufacture of a generic version.

PITC earlier registered amlodipine besylate with the Bureau of Food and Drugs.

Rivera said the 10 manufacturers ready to make the generic version of Norvasc are United Laboratories, Elite, One Pharma, American-European Pharma, Seidenham, US Generics, Drugmakers, Compact, Allied, and Sheeld. These are all members of the Pharmaceutical Corporations of the Philippines Inc.

Drugs that are already off patent are open to production by anyone.

Rivera said PITC has formed with IP Philippines a technical working group to review all medicines that will soon go off-patent.

He said PITC is similarly calling on pharmaceutical companies to invoke the trade-related intellectual property rights (TRIPS) agreement of the World Trade Organization in applying for the registration of soon-to-expire patents ahead of the nine-month window.

This way, he said, cheaper medicines could be made available immediately upon expiration of their patents.

Rivera said PITC’s bid to cancel the patent of Norvasc ahead of its June 13 expiry is intended to strengthen its defense against Pfizer which has sued it and BFAD with patent infringement before the Makati regional trial court.