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20 years of the Brazilian Generics Law

On February 10, 2019, the 20th anniversary of Law No. 9,787/99 was celebrated. This law regulated the entry of generic medicines in Brazil. Since its enactment, the landscape of the Brazilian pharmaceutical industry has been deeply changed, due to the increase of access to medicines, ensuring the right to public health.

According to said law, a generic drug is one similar to a reference or innovative product, which intends to be interchangeable therewith, in general manufactured after the expiration or waiver of patent protection or other exclusive rights, provided that it proves effectiveness, safety and quality, and is named by the Brazilian Common Denomination (BCD) or, in absence thereof, by the International Common Denomination (ICD).

In the last 20 years, more than 3,800 generic drugs have been registered before the Brazilian Health Surveillance Agency (ANVISA), in the main therapeutic classes. Moreover, this sector expands more than 10% per year worldwide and transacts between US$150 and US$200 billion.

Should you need more information about this topic, we invite you to read our publication available at