Five companies to share 180 day marketing exclusivity
Five Indian pharmaceuticals companie – Aurobindo Pharma, Dr Reddy’s Labs, Lupin, Sun Pharma and Torrent – have received US Food and Drug Administration (FDA) permission to market generic versions of blockbuster antidepressant drug Cymbalta following the expiry of Eli Lilly’s patent in early December. The six Indian companies are to share the 180 day marketing exclusivity.
While Lupin’s US subsidiary, which has also received the FDA nod for three other drugs, has already launched Cymbalta’s generic version of the capsules in the domestic market, the other Indian pharmaceutical majors are preparing to notch up collective sales of around US$120m to $180m during the exclusivity period.
According to industry data, Cymbalta achieved annual US sales of $5.43bn and is the fifth largest selling drug in the world. Launched in 2004, it accounted for 22% of Lilly's $22.6bn revenue in the last financial year.
Over the last two years, US-based Lilly has lost patent protection for several of its top selling drugs, including the antipsychotic Zyprexa, which had global sales in excess of $5bn a year. Earlier in 2013, Lilly also lost US patent protection for its antidiabetic drug Humalog, which had annual sales of $2.4bn in the US.
Grabbing a small share of the highest selling drug market in the US is turning out to be a major boost to the revenues of Indian pharmaceutical companies.