A study carried out by Brazilian generics association Pro Genericos has highlighted that the expiration of a host of branded drugs this year will greatly benefit the Brazilian industry.
IHS Global Insight perspective | |
Significance | A patent cliff for branded drugs approaching at the end of 2013 is expected to boost the Brazilian domestic generic sector, according to the Pro Genericos association. The sales expected by Pro Genericos from the generic presentations of the top ten of these drugs upon patent expiration is BRL1 billion (USD454 million). |
Implications | The patent expiration of some of the top-selling branded drugs, including some blockbusters, will enhance local production and sales of the copies of the most-used drugs for chronic diseases. |
Outlook | As a result of upcoming patent expirations, as well as a mix of successfully enacted pro-generic policies, the size of the generics market in the country is expected to increase in capacity, and confirm its status as the strongest generics market in Latin America, competing with some of the strongest emerging generics markets in the Western world. |
The wave of expirations of branded drugs this year in Brazil is expected to boost the domestic sector, according to the Pro Genericos association. According to the source, the sales of the top ten of these branded drugs was BRL760 million (USD436 million) in the last 12 months, but the sales expected by Pro Genericos for the generic presentations upon patent expiration is BRL1 billion, a market expansion of 10% year on year.
Among the most famous of these drugs to go off-patent is Cialis (tadalafil; GlaxoSmithKline, UK), for the treatment of erectile dysfunction. The cost in Brazil for a 28-tablet 5mg presentation is BRL326, whereas, according to Pro Genericos, its generic version will cost an average of BRL212.27. According to the source, the branded version of Cialis had a market value of BRL256 million between September 2012 and August 2013. Other drugs that will soon be targeted by generic competition are Cymbalta (duloxetine; Eli Lilly, US), a serotonin-norepinephrine reuptake inhibitor (SNRI) for the treatment of major depressive disorders, and Avodart (duasteride, GSK) for the treatment of benign prostatic hyperplasia.
Outlook and implications
The patent expiration of top-selling branded drugs, some of which are blockbusters, on the Brazilian market will have an undoubted positive impact on the growth of the domestic generics sector, as it will enhance local production and sales of the copies of the most used drugs for chronic diseases. The generics sector in Brazil is already considered the top market in Latin America and one of the most fertile worldwide as a result of the government's strong pro-generic policies.
Brazil is undergoing a shift in prescription culture that will also benefit the uptake of generics in the country, as more generic options are being prescribed by physicians as well as an increasing number of patients who are keen to use generic versions rather than branded versions of drugs. The increase in the prescription and use of generic drugs will create the need for a build-up of capacity for the domestic industry, and an increasing number of foreign generic firms are expected to set up or reinforce their operations in Brazil. Generics will provide a more sustainable option for the treatment of a variety of diseases that are rising in incidence in the country, and local generic firms are expected to be able to meet internal demand as the sector grows. The Brazilian pharmaceutical sector is expected to double its sales volume in the next five years through more investment, and generics will account for a substantial part of this income as patients increasingly gain more confidence in these products, as a cheaper and reliable option, specifically those less able to afford branded drugs.