The Telegraph
Since 1st March, 1999
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Bedroom pill ache in boardroom
- Weekend clones strike when original is caught in patent red tape

New Delhi, March 26: The weekend sex drug has hit the Indian markets; and it’s better than Viagra!

The trouble is that two Indian pharmaceutical companies — Ranbaxy and Ajanta Pharmaceuticals — have come up with clones of the wonder drug even before Eli Lilly of the US could press its claim to introduce its blockbuster drug called Cialis in India.

Cialis is a long-lasting, lifestyle drug — directed at people with erectile dysfunctional problems — that one can pop on a Friday and stay super active over the weekend. It is the first sexual tablet that allows up to 36 hours to choose the moment that’s right to be intimate.

Pfizer’s Viagra has to be popped an hour in advance and its effect wears off in about four hours — which exacerbates stress and anxiety levels in a pill popper.

The Indian clones of Cialis — which were introduced early this month — have brought into sharp focus India’s quixotic patent regulations. Eli Lilly had applied for exclusive marketing rights (EMRs) for its drug in an attempt to stall knockoffs by reengineered clones.

The EMR is a provision incorporated in the Patents Act of 1970 through an amendment in 1999. Under this amendment, it is possible to make an application for patent protection for a drug developed in India or abroad. However, the application will not be processed until the end of 2004.

The proviso provides for exclusive marketing rights for the drug for a period of five years or till the date of grant of the patent or the date of rejection of the patent application, whichever is earlier.

“It is a classic case of the clone coming before the original. We have applied for an exclusive marketing right and are very sure that we will not market it in India unless we get an EMR,” an official spokesperson for Eli Lilly and Company (India) said.

It took Eli Lilly almost 10 years and hundreds of millions of dollars in development costs to create the drug — and they are upset over the local clones.

The Cialis clones will in all probability be one of the last patent knockoffs in India which will switch over to a product patent regime from January 1, 2005.

Ranbaxy sells its product — which it calls ForZest — at a rock-bottom price of Rs 19.50 for a 10-mg dose and Rs 29.50 per tablet for a 20-mg dose. The tablets, to be sold on prescription only, are available in a strip of four. Ajanta — which was the first out with the weekend sex drug — markets it under the brand name Tadalis.

Cialis, which is manufactured at Eli Lilly’s plant in Puerto Rico, sells for about $10 (Rs 450) per pill, which explains why the clones do so well in India.

Viagra — which Pfizer launched with great fanfare in 1998 — is made from a bulk drug called sildenafil citrate. It created a storm in bedrooms across the world but also carried health warnings against indiscriminate use by people who had heart problems. Viagra has racked up annual sales of $1.7 billion with about 23 million men having popped it around the world — making it a formidable competitor in this drug segment.

Cialis was launched in Europe about nine months ago and has been well received. In December 2003, Cialis had a 33 per cent share in France, 30 per cent in Germany, 27 per cent in Italy and 18 per cent in both Spain and Britain, the firm said.

The yellow pill is the third anti-impotence drug to win approval from the US Food and Drug Administration in the past five years. Competitors are Viagra and Levitra, a medication from Bayer AG and GlaxoSmithKline.

Cialis works by relaxing blood vessels in the penis, allowing increased blood flow that causes an erection. Like Viagra and Levitra, it does have several side effects and restrictions. The drug should not be used in combination with nitroglycerin tablets or medicines used to treat high blood pressure.

It is also not recommended for men who have suffered a stroke or heart attack in the past six months. Side effects include headache, indigestion, back pain, muscle aches and stuffy nose. A few patients have also experienced blurred vision, according to the FDA.

There is another downside: one pill usually equals one sexual attempt. Icos Corp, the biotechnology company that helped develop the drug for Eli Lilly, said of the 40,000 records of sexual attempts chronicled during its research, only a handful of men had sex more than once during the 36-hour period on one dose.

Drug patent knockoffs have given India a bad name in the world of pharmaceuticals. Drug makers spend billions of dollars in research to come up with products whose commercial potential they cannot fully exploit in countries like India that do not have a product patent regime.

Besides Ranbaxy and Ajanta, two others are waiting to jump on to the Cialis bandwagon: Cadila Pharmaceuticals and Ritchie Pharmaceuticals.

Currently, the available oral medication for management of erectile dysfunction is sildenafil, whose market size is valued at Rs 70 crore in India. Ranbaxy’s Caverta is a leading player while there are many others in the fray.

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