According to the UK’s Medicines Health products Regulatory Agency’s latest list of authorisations, published at end-February 2023, Cialis Together (tadalafil 10mg, Opella Healthcare / Sanofi) has been granted P (Pharmacy medicine OTC) registration. This is the second such OTC approval globally, following the world first Rx-to-OTC switch of Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) by Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) in February 2022; it is now available OTC (launched in October 2022) alongside a rival version from Polpharma’s Maxigra, which launched first in June 2022.
OTC activity in the erectile dysfunction category is intensifying globally. Futura Medical, which is aiming for its topical gel formulation MED3000 – branded as Eroxon – to become the first major ED treatment available OTC in USA, said in late 2022 that the FDA had confirmed the dossier was under formal review and “indicated that [it] had successfully passed the initial technical screening”. Granting of US marketing authorisation was said to be on track to be achieved by end-Q1 2023.
Nicholas Hall Writes: I’m interested in our lead story as we’re all keen to know what will happen when Viatris’ Viagra meets stiff competition in its UK lead switch market, where Viagra was first to launch and has attracted no branded competitors, so that it virtually dominates the market. Poland was a different matter as Viagra came relatively late into the marketplace, by which time there were a number of sildenafil brands, sold at lower prices with mass advertising, followed by the first switch anywhere in the world of tadalafil. Not surprisingly, Viagra has had only modest results in Poland.
Now we face the prospect of OTC Viagra meeting strong branded competition in its lead market, with a formulation that might not be as well known, but in medical terms is generally recognised as superior. Will Sanofi launch Cialis Together with saturation advertising, or with a more muted campaign that seeks a secondary position in the market? This is an interesting proposition in its own right, but especially as Viagra in Europe may well change ownership in the next year.
There is still time to save up to GB£1,350 when you pre-order the 2023 edition of our Innovation in CHC report, publishing soon! Drawn from CHC New Products Tracker, this report explores innovation by marketer, region and country. It showcases 10 major ingredient trends, 5 delivery format trends and 100 key innovations from 2022. For more information, or to pre-order your copy with the pre-publication discount, contact melissa.lee@NicholasHall.com.