Gedeon Richter has told Euronews it expects to restore availability of this menopause treatment in Spain from the second half of November, but warns global restrictions may prevent it from meeting full demand in 2027.
Lenzetto, one of the hormone therapies most commonly used to relieve the symptoms of the menopause, 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 ensure a stable level of production for the rest of the year and in 2027, although it acknowledges that global supply constraints could prevent it from fully meeting current demand.
The company attributes the current shortage of the medicine in Spain to a sharp rise in demand for hormone treatments for the menopause 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, were unable to keep pace with soaring demand.
Gedeon Richter stresses that the situation is temporary and "is not related to any quality or safety issue with the medicine". The problem, the company says, is simply that very high demand has outstripped its manufacturing 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 stepping up 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 specific investment project to strengthen its manufacturing capacity. However, the company warns that scaling up pharmaceutical production takes time because of quality controls.
The company also recognises that the measures adopted will not resolve the situation overnight. It says it is working to ensure that the changes improve supply as quickly as possible.
A problem affecting other markets
The shortage of Lenzetto does not affect Spain alone. 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 find some hormone treatments used to alleviate menopausal symptoms. The lack of Lenzetto forced patients and professionals to turn to other estradiol formulations, which ended up creating a domino effect for 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 also recorded supply problems with other medicines, such as Evopad, Estradot and Bijuva.
"The supply problem began in April with Lenzetto and has, as a consequence, gone on to affect other transdermal hormone therapies such as patches and gels," Aemps said in a statement (source in Spanish) released in early October. "The Ministry of Health has been in contact with the holders of other hormone treatment options that are currently not reimbursed, in order to explore their possible inclusion in the pharmaceutical benefits 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 respond directly to the accusations, but says it maintains "close contact" with Aemps and works "in a collaborative way" with the agency to address the situation.
Gedeon Richter also says it has improved its forecasting systems in response to demand it describes as "unprecedented" and 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 meet patients' demand consistently from the second half of 2027.
