In 2000, Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) approved the marketing of 177 generic medicines in the Brazilian pharmaceutical market, see Figure 1.

The generic medicines market started to grow steadily, 19 years after the first ones were approved, reaching 5,723 registrations in 2019. In 19 years, 2,398 registrations have been cancelled, leaving 3,325 valid generic drug registrations in August 2019 [1].

In August 2019, the three active ingredients with the highest number of generic registrations were dipyrone monohydrate (n = 46), amoxicillin (n = 40) and paracetamol (n = 37), which together accounted for 19.1% of all registrations.

Figure 1: Number of generic medicines registered per year from 2000 to 2019

  
In 2017, generic medicines represented a relevant representation of the pharmaceutical market in Brazil: 41% of companies, 37% of products and 13.5% of revenues. Furthermore, in the same year, more than 1.5 billion generic medicines were sold, making it the most marketed medicine in the country. Still, compared to other countries, generic medicines in Brazil remain under-represented.

Compared to other countries where generic medicines have been longer on the market, such as France, Germany and the UK, the representation of generic medicines is 42%, 66% and 60%, respectively [1].
 
Physician and public awareness, together with financial constraints, have been the reasons why demand for generic medicines in Brazil has been increasing. The increase in sales volume has turned out to be above average revenue growth. Between 2015 and 2017, revenues from generic medicines grew by up to 28.3%, while revenues from other types of medicines grew by an average of up to 5.6%.

Editor’s comment
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Barriers to generics policy reform: a US case study

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Reference
1. Nardi EP, Silva ARA. A closer look at generic drugs: the Brazilian case. In: Lowell T. Duncan (Ed). Advances in Health and Disease. Volume 21. Nova Science Publishers; 2020. Chapter 2. ISBN: 978-1-53617-783-1.

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