Gedeon Richter has told "Euronews" it expects to resume supply of this menopause treatment in Spain from mid-November, but warns global limits may stop it meeting demand in 2027.
Lenzetto, one of the most widely used hormone treatments to relieve menopausal symptoms, will once again be available in Spanish pharmacies from the second half of November, its manufacturer Gedeon Richter has confirmed to Euronews.
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"We expect the product to be available in pharmacies from the second half of November," the pharmaceutical company said in response to questions from Euronews. Gedeon Richter says it will do "everything possible" to guarantee stable production for the rest of this year and in 2027, although it acknowledges that worldwide supply constraints may prevent it from fully covering current demand.
The company traces the origin of the current shortage of the medicine in Spain to a sharp rise in demand for menopause hormone treatments in Europe. In an email, the company explained that growth has been far higher than expected and that both manufacturing capacity and the supply of the device used to administer Lenzetto, the applicator, could not keep pace with the surge in demand.
Gedeon Richter stresses that the situation is temporary and "is not related to any problem with the quality or safety of the medicine". The issue, according to the company, is simply that high demand has outstripped its production capacity.
To increase the availability of its medicine, the laboratory says it is making full use of its current production capacity and working to expand both the number of suppliers and its manufacturing options. It is also trying to improve the supply of applicators and increase their production capacity, among other measures.
These plans include a new plant and a new production line. In Romania, Gedeon Richter has also launched a dedicated investment project to strengthen its manufacturing capacity. The company warns, however, that expanding pharmaceutical production takes time because of quality controls.
The company also acknowledges that the measures adopted will not resolve the situation overnight. It says it is working so that the changes can improve supply as quickly as possible.
A problem affecting other markets
The shortage of Lenzetto is not limited to Spain. Gedeon Richter confirms that there is currently a global shortage of the medicine, although the severity of the problems varies between markets depending on local demand, forecasting capacity and logistical possibilities.
The situation has for months made it difficult to obtain some hormone treatments used to relieve menopausal symptoms. The lack of Lenzetto forced patients and healthcare professionals to turn to other forms of estradiol, which eventually generated a domino effect on some of the alternative treatments.
The European Medicines Agency (EMA) has also identified the Lenzetto shortage and is studying possible coordinated measures at European level. In Spain, the Spanish Agency of Medicines and Medical Devices (AEMPS) has likewise recorded supply problems affecting other medicines, such as Evopad, Estradot and Bijuva.
"The supply problem started in April with Lenzetto and has subsequently affected other transdermal hormone therapies such as patches and gels," AEMPS said in a statement (source in Spanish) published in early October. "The Ministry of Health has been in contact with the holders of other hormone treatment alternatives that are currently not reimbursed, in order to explore their possible inclusion in the pharmaceutical services of the National Health System."
Richter responds to AEMPS criticism
AEMPS has pointed out that some of the supply forecasts previously communicated by Gedeon Richter "have not always been accurate" and that interruptions which could affect the continuous supply of the medicine were not reported with sufficient notice.
Asked by Euronews about these comments, the company does not directly address the allegations, but says it maintains "close contact" with AEMPS and works "in a collaborative manner" with the agency to tackle the situation.
Gedeon Richter adds that it has improved its forecasting systems in response to demand it describes as "unprecedented" and that it continues to provide information to the authorities as new data become available.
The laboratory does not, however, guarantee a full recovery of supply in the short term. The company says its goal is to be able to consistently meet patient demand from the second half of 2027.
