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Stada launches generic Exforge following patent revocation Posted 19/04/2019

German generics producer Stada Arzneimittel announced on 20 March 2019 that it is set to launch a generic version of the antihypertensive Exforge (amlodipine/valsartan combination), following the revocation of a Novartis European patent.

This will be Stada’s second attempt at launching the generic combination product. Following the initial launch, Stada and its subsidiaries were forced to withdraw the product from the market one year later in December 2017 as Novartis had obtained an interim injunction before the Düsseldorf Higher Regional Court for patent litigation, confirming the Exforge patent until July 2019. However, on 11 March 2019, Novartis’s European patent was revoked following a successful opposition filing by Stada and its subsidiaries, who claimed that the patent, which had previously been upheld by the Objection Division of the European Patent Office, would not stand in an appeal before the Board of Appeal of the European Patent Office.

Stada will be one of the first manufacturers to launch the generic amlodipine/valsartan product following the revocation of Novartis’s European patent. After the sales launch in Spain, numerous Stada subsidiaries will launch the combination product in their markets, including Germany.

According to Stada CEO Peter Goldschmidt ‘Amlodipine/valsartan is an important expansion of our portfolio of blood-pressure-lowering drugs and will make a positive contribution to our sales growth in 2019’. Dr Şenay Has, Vice President Intellectual Property at Stada adds: ‘The introduction of this product is a prime example of both the strategic vision and the agility within our Group. We recognized the opportunity of the patent’s invalidity early on, challenged it in June 2016, ultimately brought the patent down, and now made everything possible quickly, so that we were ready to deliver immediately after the decision of the European Patent Office’.

Stada is the only independent generics producer in Germany. The company also produces branded drug products, including its Grippostad (paracetamol/caffeine/phenylephrine hydrochloride) cold medication and Ladivalsun protection lotion [1].

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1. GaBI Online - Generics and Biosimilars Initiative. German drugmaker Stada to be sold for over US$5 billion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 19]. Available from: www.gabionline.net/Pharma-News/German-drugmaker-Stada-to-be-sold-for-over-US-5-billion

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