End of patent dispute - Exforge generics: Stada celebrates comeback
Berlin - The path is clear for Exforge generics: The generic products of the antihypertensive with the active ingredient combination Valsartan/Amlodipine take the second try. After the generics had firstlaunched in 2017, they had to be taken off the market only one year later. Novartis had obtained an interim injunction. But now the European patent has been revoked. Stada is all set.
Within the next few days, the Bad Vilbel-based group will launch the active ingredient combination in Germany. Sales started in Spain. Other Stada subsidiaries will also follow with their generics. On December 14, 2017, generics manufacturers were forced to withdraw their combination products from the market; numerous rebate agreements could no longer be served. However, the originator had protected its own generics - Hexal and 1A Pharma. The subsidiaries had rebate agreements with various health insurance companies such as AOK and BBK. Novartis had obtained an interim injunction before the Düsseldorf Higher Regional Court for patent litigation confirming the Exforge patent until July 2019.
But now it has been revoked. The generic manufacturers had filed an opposition because the companies were of the opinion that the claimed 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. The case is now closed. On 11 March, the European patent EP 2 322 174 was revoked.
“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,” says CEO Peter Goldschmidt, explaining the role of the product for STADA. Dr. Şenay Has, Vice President Intellectual Property at STADA and in charge at STADA in the dispute before the European Patent Office, 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 first company to reintroduce generics into the German market.
The fixed combination is available in different dosages. Combinations of amlodipine/valsartan with 5/80 mg, 5/160 mg or 10/160 mg are possible. In addition, the duo can also be purchased in combination with hydrochlorothiazide. Treatment with the fixed combination is suitable for patients whose blood pressure cannot be regulated sufficiently by monotherapy with amlodipine and valsartan. Amlodipine inhibits the influx of calcium into the heart muscle cells. The active substance has blood pressure lowering effects due to a direct relaxing influence on the smooth vascular muscles and the associated reduction of peripheral vascular resistance. The contractility of the heart muscle is calcium-dependent and is regulated by its inflow.
Valsartan is a specific angiotensin II receptor antagonist and selectively blocks the AT1 receptor. Sartan causes vasodilatation and reduces the release of aldosterone - sodium and water excretion are increased. Last summer, a recall wave was started around the antihypertensive.
Only a few days ago, Stada had reported another success. Stada and Aliud are allowed to continue selling the generics for Inegy (Ezetimib/Simvastatin, MSD Sharp & Dohme). The Bad Vilbel-based group achieved a success before the Düsseldorf Higher Regional Court (OLG). MSD obtained a temporary injunction in May last year. The generic companies had been prohibited from offering, placing on the market or owning drugs with the active ingredient combination Ezetimib/Simvastatin in Germany.
Translated by STADA Corporate Communications