Before its patent expiry, this drug was the leading Hepatitis medication in Albania with over 500 patients treated. Since then, 4 generics came to the market with a low co-pay for patients. Still, about 200 patients have chosen to pay a higher co-pay, just to have access to this trusted innovative medicine.
Following a long wait for reimbursement in Serbia, this innovative medicine was approved just months before two leading generic companies had their products reimbursed. Today, 7 years later, this off-patent innovative drug still commands 60% MS. The sales were over EUR 1 million in 2022.
Physicians expressed a need for a steady supply of this older epilepsy drug that was sporadically available only in hospitals. Lenis approached the product owner and managed to obtain reimbursement for this off-patent unlicensed medicine so that it can now be dispensed in pharmacies. The regular supply enabled doctors to replace some less suitable therapies with this medicine. We sold around 4.000 packs in Slovenia within the first full year on the market, and started selling it to Serbia, as well.
Based on the request of a KOL, Lenis started distributing this medicine 10 years ago as a reimbursed unlicensed Rx medicine in Slovenia even before it had marketing authorization in any country (“Special” status in UK). Due to successful market penetration the product owner decided to register the drug in Slovenia. Over the years, this product has become the standard of care with over 17.000 doses sold in 2022.
Gastro-resistant capsules were launched as reimbursed unlicensed prescription medicine and soon completely replaced an immediate release medicine with the same active ingredient. It is now the standard of care for patients before and on dialysis, because it contributes to better disease management for patients, and saves the health insurance fund money. After reaching the agreed sales threshold, Lenis helped the principal to obtain marketing authorization and a favorable reimbursement price.
After the Slovenian Health Insurance Fund expressed interest, Lenis started supplying and obtained reimbursement for this unlicensed medicine more than 10 years ago.
The market potential then was estimated by a leading specialist to be 10.000 packs per year. Since then, this product became the leading UTI medicine in Slovenia with over 60.000 packs sold in 2022. Over the years, Lenis managed to mitigate supply chain issues with a variety of regulatory and commercial tools.
As a local regulatory agent, Lenis helped the principal obtain marketing authorization through a shortened procedure (Cyprus clause). This is still the only Rx product in the country with an MA based on the Cyprus clause.