drug
tacrolimus ER
Marketedupdated 3mo agoby Veloxis Pharmaceuticals Inc
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 9 approved and 18 investigational indications.
all catalysts(8)
approval · 8
Nov 10, 2020
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Nov 10, 2020
approval
TACROLIMUS — FDA approval
tacrolimus ER
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Sep 26, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Sep 26, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Oct 17, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Oct 17, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Oct 17, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Oct 17, 2025
approval
TACROLIMUS — FDA approval
tacrolimus ER
→
Trials studying tacrolimus ER
- phase2Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
- phase3A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
- phase2Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
- phase3A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
- phase3Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
- phase2CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke
- phase4Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants
- phase3A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Patent cliff
source: FDA Orange Bookfirst barrier falls
May 30, 2028
~1.8 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (30)
- Aug 30, 2028method-of-use (U-2678)US 86642392.0y
- Aug 30, 2028method-of-use (U-2678)US 86642392.0y
- Aug 30, 2028method-of-use (U-2678)US 86642392.0y
- Aug 30, 2028formulationUS 86859982.0y
- Aug 30, 2028formulationUS 86859982.0y
- Aug 30, 2028formulationUS 86859982.0y
- May 30, 2028formulationUS 101661901.8y
- May 30, 2028formulationUS 101661901.8y
- May 30, 2028formulationUS 101661901.8y
- May 30, 2028method-of-use (U-2677)US 108641991.8y
- May 30, 2028method-of-use (U-2678)US 108641991.8y
- May 30, 2028method-of-use (U-2678)US 108641991.8y
- May 30, 2028method-of-use (U-2678)US 111100811.8y
- May 30, 2028method-of-use (U-2678)US 111100811.8y
- May 30, 2028method-of-use (U-2678)US 111100811.8y
- May 30, 2028method-of-use (U-2677)US 111233311.8y
- May 30, 2028method-of-use (U-2677)US 111233311.8y
- May 30, 2028method-of-use (U-2677)US 111233311.8y
- May 30, 2028formulationUS 114198231.8y
- May 30, 2028formulationUS 114198231.8y
- May 30, 2028formulationUS 114198231.8y
- May 30, 2028method-of-use (U-2678)US 120831031.8y
- May 30, 2028method-of-use (U-2678)US 120831031.8y
- May 30, 2028method-of-use (U-2678)US 120831031.8y
- May 30, 2028formulationUS 124030951.8y
- May 30, 2028formulationUS 124030951.8y
- May 30, 2028formulationUS 124030951.8y
- May 30, 2028formulationUS 95499181.8y
- May 30, 2028formulationUS 95499181.8y
- May 30, 2028formulationUS 95499181.8y
FDA exclusivities (6)
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.9y
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