Generic olanzapine now approved in US

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Generic olanzapine now approved in US

Generics/News | Posted 04/11/2011 0 Post your comment

Eli Lilly has no safe haven left as the FDA announced on 24 October 2011 that it had approved the first generic olanzapine (for treating schizophrenia and bipolar disorder) drugs, one day after the company lost its patent protection on Zyprexa (olanzapine) in the US on 23 October 2011 [1].

The generic olanzapine tablets will be manufactured by Dr Reddy’s Laboratories and Teva and orally disintegrating tablets will be manufactured by Apotex, Dr Reddy’s Laboratories and Par Pharmaceuticals.

The generics makers join an ever growing list of those already producing copies of the blockbuster antipsychotic drug Zyprexa (olanzapine). In Europe, Ranbaxy launched its generic version in Spain on 25 April 2011 [3], Actavis launched a generic version in Austria, Denmark, Finland, France, Germany, Ireland, Italy, Romania, Sweden, The Netherlands and the UK on 30 September 2011 [4] and Navamedic’s generic olanzapine was launched in Finland and the Netherlands on 12 October 2011 [5].

Generic olanzapine is great news for generics manufacturers and patients, but not such good news for Eli Lilly, who attributed nearly 22% (US$5 billion) of their 2010 sales to Zyprexa [2]. However, Eli Lilly is not taking this lying down and has already signed a marketing and distribution agreement with US-based Prasco to market an authorised generic version of Zyprexa (olanzapine) in the US.

It seems that there may well be life after Zyprexa for Eli Lilly as, although it posted a 5% decline in third quarter 2011 earnings, the company reported that sales were up 9% compared to the same period in 2010. Eli Lilly attributed the increase in sales in part to the outstanding performances of the antidepressant/fibromyalgia blockbuster Cymbalta (duloxetine) and the lung cancer drug Alimta (pemtrexed), who generated US$1 billion and US$630 million in revenues, respectively.

Eli Lilly commented that ‘the company expects the introduction of generics to result in a rapid and severe decline in Zyprexa sales’. This is definitely to be expected, as once drugs lose patent protection, lower-price generics rapidly gain market share, often siphoning off as much as 90% of sales. Benefits to patients are substantial, with generics averaging about 30% of the price of the brand-name originals [6].

References

1. Global BC. Drugmaker Eli Lilly's 3rd-quarter profit falls 5 per cent as Zyprexa patent expiration nears. 20 October 2011.

2. GaBI Online - Generics and Biosimilars Initiative. 2011’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 04]. Available from: www.gabionline.net/Policies-Legislation/2011-s-biggest-patent-expiries

3. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy launches generic olanzapine in Spain [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 04]. Available from: www.gabionline.net/Generics/News/Ranbaxy-launches-generic-olanzapine-in-Spain

4. GaBI Online - Generics and Biosimilars Initiative. Actavis launches generic olanzapine in 11 European markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 04]. Available from: www.gabionline.net/Generics/News/Actavis-launches-generic-olanzapine-in-11-European-markets

5. GaBI Online - Generics and Biosimilars Initiative. Another olanzapine generic hits the market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 04]. Available from: www.gabionline.net/Generics/News/Another-olanzapine-generic-hits-the-market

6. GaBI Online - Generics and Biosimilars Initiative. Generics of antibiotic Levaquin approved by FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 04]. Available from: www.gabionline.net/Pharma-News/Generics-of-antibiotic-Levaquin-approved-by-FDA