Changing the mood of Brazilian antidepressant market; fake Levitra

The Vice President of Brazil’s Superior Court of Justice (STJ), Minister Felix Fischer, has restored the power of the National Health Surveillance Agency (ANVISA) to grant registration of generic medicines and the like, based on the active ingredient escitalopram, an antidepressant.

The judge of first instance had decided that ANVISA refrain from granting registration to a third party not authorized by Lundbeck Brazil Ltda - the Denmark-headquartered producer of Lexapro (escitalopram), the reference medical product - to use test results and data of the dossier sent by the company for the registration of the drug, according to the IP Tango blog site.

Also, the court held the invalidity of any drug registration already granted based on this dossier, in particular those obtained by Ache Pharmaceutical Laboratories and Biosintetica Pharmaceuticals, which are manufacturers of similar drugs. The judge applied the term of 10 years to protect the rights of data exclusivity – in this case due to expire in September 2012.