Tuesday, April 2, 2013

Teva files Generic Symbicort for Approval in Europe

Teva in its 20-F filing for 2012 has announced that it has  filed an Market Authorization Application with the Eurpean regulators for approval of Budesonide Formoterol Spiromax. Budesonide Formoterol Spiromax  combination utilizes Teva's  proprietary Spiromax device. The combination was studied in clinical trials and results demonstrate the same is bio-equivalent to the marketed product (Symbicort Turbohaler ). Teva submitted a European marketing authorization application in January 2013.

Symbicort  Sales (2012 Sales: US-$1003m and EU- $1313m; Established ROW-$443m; Emerging market- $435m)

Symbicort Patent Expiry

US: 2014 (combination); 2023 (formulation); 2026 (pMDI device)

EU: 2018 (formulation); 2019 (Turbuhaler device)

Canada: 2018 (formulation); 2019 (Turbuhaler device)

Japan: 2017 (combination); 2018 (formulation); 2019 (Turbuhaler device)


Teva is also conducting clinical trials to evaluate an improved formulation of Advair Diskus. Teva's Fluticasone Propionate Salmeterol Spiromax is a new formulation of this combination and is delivered using its patented Spiromax device. It is designed to have an enhanced lung delivery which should allow lower doses to achieve the same clinical outcomes as Advair Diskus. Phase II trials commenced in 2012.


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