Brazil’s liberalising switch environment

Two waves of Rx-to-OTC reclassifications are about to transform Brazil’s OTC market. In August 2016 ANVISA published new Rx-to-OTC switch regulations and there are currently 26 ingredients awaiting review by ANVISA. ANVISA also published Instrução Normativa #11 (September 2016) listing 35 therapeutic groups for which switch is possible – the updated OTC list published at the time is available [in Portuguese] here.

Sanofi and Aché have since received switch approval for allergy remedies Allegra and Talerc respectively. (According to Instrução Normativa #11 restrictions for OTC antihistamines are limited to adrenergics and corticoids only, excluding topical hydrocortisone.)

Fexofenadine-based Allegra has been switched to OTC in all adult and children’s pack sizes and formats – including capsules (60mg); coated tablets (60mg, 120mg, 180mg); and paediatric suspension (6mg / ml) – except combination Allegra-D (which also contains pseudoephedrine).

Allegra Talerc.png

Current Rx packaging for Allegra and Talerc

Meanwhile, Talerc formulated with epinastine hydrochloride 10mg, is now available OTC in packs of 10 tablets for adults and children aged 12+.

Aché has geared its future towards the opening up of Brazil’s OTC market, unveiling its Innovation Centre in 2015 and earmarking seven brands that it expects to be able to switch. Though the company doesn’t have a blockbuster OTC brand in systemic analgesics – by far Brazil’s largest OTC subcategory – it expects to develop its portfolio here.

Over the next few decades, Aché has estimated that its OTC product portfolio will have expanded significantly. In 2015, OTCs represented just 11% of Aché sales; however, the company’s long-term strategic plan forecasts that it will be a Top 3 OTC company by 2030.

For more info on these developments, be sure to subscribe to Nicholas Hall’s OTC INSIGHT Latin America. Also, Nicholas Hall will be visiting Sao Paulo to lead our 4th Latin American OTC Conference on 28-29 November 2018. You can expect invigorating presentations from industry experts about the Latin American consumer healthcare industry. Plus, we will be hosting our inaugural Latin American OTC Marketing Awards 2018! You can book your place today, or find out more by contact

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