Supply disruptions and manufacturer delays

Spain's Agency of Medicines and Medical Devices (AEMPS) reported on 2 October 2026 that widespread shortages of transdermal estradiol therapies will persist into 2027. The disruption originated in March 2026 with Lenzetto, a transdermal spray marketed by Gedeon Richter containing 1.52 mg of estradiol per dose. The regulator noted that initial user reports surfaced in February 2026, after which the manufacturer reported normal operations before subsequently acknowledging device issues and depleted inventories across all markets. Gedeon Richter announced that progressive deliveries would resume in November 2026 and extend through 2027. AEMPS cautioned that forecasts from the company have not always proved accurate.

Strained alternatives and public reimbursement talks

The absence of Lenzetto triggered cascading supply shortages across other transdermal estradiol treatments, including patches and gels. The Ministry of Health, headed by Mónica García, approached manufacturers of non-subsidized alternatives to explore their integration into the National Health System (SNS) pharmaceutical catalog. However, AEMPS confirmed that none of the contacted pharmaceutical firms have formally submitted an application for public funding. Manufacturers remain reluctant to accept state price controls or commit to sudden production increases. Meanwhile, Bexat Farmacéutica notified regulators of the permanent cessation of commercialization for its Estradot patches, although AEMPS described its market share as minimal.

Surging demand and clinical advantages

Demand for hormone replacement therapy has expanded rapidly across Spain in recent years. Data from the Catalan Society of Obstetrics and Gynecology indicates that hormone therapy usage among climacteric women rose from 3% to 9%, while an estimated 20% to 25% (roughly 1.2 million women) experience severe symptoms. Annual sales of Lenzetto in Spain grew from 13,000 units in 2018 to 123,000 units in 2024. Silvia P. González Rodríguez of the Spanish Association for the Study of Menopause explained that patient inquiries increased as safety perceptions improved and summer temperature extremes exacerbated vasomotor symptoms.

201813,000

2024123,000

2018

13000 packages

2024

123000 packages

Data from the article text

Transdermal administration remains the preferred clinical route because it bypasses liver metabolism and reduces thrombosis risks by two to four times compared to oral tablets, according to research from the Centre for Addiction and Mental Health at the University of Toronto.

Clinical prioritization and regional contingency plans

Health authorities are coordinating with scientific societies to prioritize existing patients on transdermal therapies while directing new patients toward oral alternatives when medically viable. Supplies of Evopad, currently the only subsidized estradiol patch in Spain, are scheduled to receive new shipments by mid-October 2026, with normalized distribution projected for November 2026. The distributor of Estraderm patches anticipates adequate stock for its current market share, while Seid Lab increased output of Oestraclin Gel, which remains outside public coverage and costs approximately 30 times more than the subsidized spray. In Catalonia, regional health officials prepared authorizations for community pharmacies to formulate compounded estradiol preparations if commercial supply issues remain unresolved within one month.

Maddalena Santirocco, a gynecologist at the Women's clinic in Barcelona, outlined the scope of climacteric symptoms:

“It is not a disease, but it is a condition that causes very significant symptoms: hot flashes, night sweats, sleep disruption, genitourinary symptoms, and other conditions that can affect quality of life.”