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Adalvo announces successful Pivotal BE study for Dydrogesterone tablets

09 December 2022

Adalvo is delighted to announce the successful Pivotal BE study of our Dydrogesterone 10mg tablets. Our dossier is ready for immediate submission and we expect Adalvo to be amongst the first wave of filers in the EU.

Our product has been developed based on the reference brand Duphaston and is indicated in the treatment of progesterone deficiency and hormone replacement. The product sold around $ 406mio globally in 2021, with Global 3Y CAGR at 12%, according to IQVIA.

Dydrogesterone is being developed by our sister company, which forms part of the Aztiq group, having a state-of-the-art R&D and manufacturing facility, with several GMP inspections already successfully completed.

We are very proud of this achievement, considering the difficulty and complexities attributed to development of this product. Based on this positive achievement, we continue to transform our Women's Health portfolio becoming a distinguished player in this domain, offering an array of additional products, as per below:

  • Dienogest, 2 mg 
  • Levonorgestrel, 1,5 mg 
  • Levonorgestrel+ Ethinylestradiol, 0.10mg+0.02mg 
  • Levonorgestrel+ Ethinylestradiol, 0.15mg+0.03mg 
  • Drospirenone + Ethinylestradiol, 3mg+0.03mg 
  • Drospirenone + Ethinylestradiol, 3mg+0.02mg
  • Desogestrel + Ethinylestradiol, 0.10 mg + 0.02 mg 
  • Desogestrel + Ethinylestradiol, 0.15mg+0.03mg
  • Norethisterone + Estradiol, 0.5mg+1mg 
  • Norethisterone, 5 mg 
  • Desogestrel, 75 mcg
  • Cyproterone + Ethinylestradiol, 2 mg + 0.035 mg 
  • Dydrogesterone, 10mg