NDATOPICALOINTMENT
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
PROTOPIC (tacrolimus) by Leo Pharma is protein, fkbp-12. Approved for kidney transplantation, liver transplantation, heart transplantation and 1 more indications. First approved in 2000.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTOPIC (tacrolimus) is a calcineurin inhibitor topical ointment approved in 2000 for treating atopic dermatitis, psoriasis, and other inflammatory and immune-mediated conditions. It works by inhibiting T-lymphocyte activation and proliferation through blockade of calcineurin phosphatase activity, preventing transcription factor translocation and cytokine production. The drug has been used across 21 indications including organ transplantation, autoimmune diseases, and hematologic malignancies.
$11KPart D
LOE ApproachingWith LOE approaching and minimal Part D spending, the PROTOPIC brand team faces significant portfolio pressure and likely operates in maintenance-mode with smaller commercial infrastructure than peak-stage products.
Mechanism of Action
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors…
Indications (4)
Worked on PROTOPIC at Leo Pharma? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.