US court rejects Ranbaxy challenge

A federal court in the United States has rejected Ranbaxy's challenge to Pfizer's patent on its anti-fungal medicine flucanozole sold under the brand Diflucan.

The district court in Washington has ruled that Ranbaxy would not be able to launch its generic version of the medicine in the US till July 29 2004, when the Pfizer patent expires.

Ranbaxy had got USFDA approval in May last year to manufacture and market its flucanozole (strengths 50 mg, 100 mg, 150 mg, and 200 mg) in the US.

The patent on the drug was to expire on January 29, 2004. But Pfizer got a six-month extension on the grounds that it was testing a pediatric version. This was challenged by Ranbaxy.

However, the court ruled last week that the six-month exclusivity awarded to Pfizer for testing the drug for use in children was valid and that Ranbaxy could not sell its cheaper generic versions of the medicine in the US until that period runs out.

When contacted, a Ranbaxy spokesperson said that the court ruling was not a blow to the company.

"We thought we could have launched earlier. But now we will launch our flucanozole once Pfizer's patent runs out," the spokesperson said.

Fluconazole is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to candida), oropharyngeal and esophageal candidiasis, and cryptococcal meningitis.

Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Diflucan recorded sales of $1.2 billion in 2003.

Generic companies have for long been complaining of "evergreening" of patents by Big Pharma -- extension of patents on one pretext or the other to keep competition from cheaper generic versions of the drug away.

It is worth noting that Ranbaxy has also challenged a patent of Pfizer on the cholesterol-lowering drug Lipitor, the world's largest selling medicine.

Pfizer is the world's largest drugmaker with a turnover of $45.2 billion in 2003. Ranbaxy is India's top pharmaceutical company with a turnover of $961 million in 2003.

Erectile dysfunction drug launched: Ranbaxy Laboratories Ltd today announced the launch of its tadalafil under the brand Forzest in India for the treatment of erectile dysfunction in men.

Tadalafil was innovated by Eli Lilly which sells it under the hugely popular brand, Cialis. Ranbaxy is the first to launch the drug in India, even before Eli Lilly.

Tadalafil is seen as giving more freedom of choice than sildenafil (Pfizer's Viagra) and has been called "the weekend pill."

It acts faster than sildenafil and also has a longer therapeutic window. While sildenafil is to be taken an hour in advance, tadalafil shows effect in 16 minutes and remain effective for 36 hours.

It is worth noting that most Indian pharmaceutical companies have launched their sildenafil in the country. The total market for the drug in India is estimated at Rs 70 crore (Rs billion). Ranbaxy's Caverta is the leading player in the segment.

Commenting on the product launch, Sanjeev I Dani, regional director (India operations), Ranbaxy, said: "The introduction of Forzest will provide Indian doctors with best-in-class and contemporary therapeutic option for management of erectile dysfunction, which also gives greater time window to the patients".

Within the pharmaceutical industry, the launch is being seen as one of the last clones of global blockbusters before the window of opportunity shuts on January 1, 2005.

On that day, the country will revert to a regime of product patents after a gap of over 30 years. The lack of product patents has helped Indian drug companies to come up with clones of best-selling patented medicine by using non-infringing processes.

Market watchers also expect others to launch their tadalafil over the next few weeks as more and more companies reverse-engineer the product.

There are 40-50 brands of each drug in the market. Over the years, this has made India the most competitive pharmaceutical market in the world

Erectile dysfunction is a seriously under-diagnosed condition, which largely goes untreated due to embarrassment of patients. It is estimated that about 150 million people suffer from erectile dysfunction and about 9 out of every 10 men do not seek treatment.

In India, it is estimated that about 50 million patients suffer from erectile dysfunction. Studies also indicate that men with diabetes have 3-fold higher incidence of erectile dysfunction and 50 per cent of them develop the condition within 10 years of being diagnosed with diabetes.