We are excited to announce we have received DCP approval across EU markets for our generic tacrolimus topical ointment (0.03% and 0.1% strengths), further expanding our dermatology portfolio.
Based on the reference brand, Protopic, Tacrolimus is indicated for moderate to severe atopic dermatitis (eczema), one of the world’s most common inflammatory skin conditions.
It often begins in early childhood, with 85% of cases presenting in the first year of life, but it also affects many adults. The most characteristic symptom is persistent, often severe itching, with cycles of flare-ups and remission.
For many patients, managing these flares and extending symptom-free periods remains a key challenge.
As a non-corticosteroid therapy, tacrolimus avoids the skin thinning associated with long-term steroid use, making it suitable for sensitive areas such as the face and neck, and supporting long-term management.
Interested in adding tacrolimus ointment to your portfolio? Contact us to find out more.
The approval covers both acute treatment (twice daily) and once-daily maintenance to help prevent recurrence. The 0.03% strength is suitable for adults and children aged two and over, while the 0.1% strength is indicated for adults.
This dual-use profile is clinically significant, giving prescribers and patients a single, flexible option across the treatment cycle.
Global sales of tacrolimus reached $971.8M in 2025, according to IQVIA, reflecting a CAGR of 5.7% from 2023 to 2025, with stronger year-on-year growth in 2025.
The approval adds tacrolimus to Adalvo’s growing dermatology portfolio and supports the company’s focus on making essential therapies more widely available to patients.
To discuss licensing or distribution opportunities for tacrolimus, contact us.