drug
tacrolimus ER
Marketedupdated 5mo 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
→
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
- phase3A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
- phase3A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
- phase3Phase 3 Randomized Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
- phase3A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
- phase3Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
- phase2High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
- 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
- phase2Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
Patent cliff
source: FDA Orange Bookfirst barrier falls
May 30, 2028
~1.7 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 86642391.9y
- Aug 30, 2028method-of-use (U-2678)US 86642391.9y
- Aug 30, 2028method-of-use (U-2678)US 86642391.9y
- Aug 30, 2028formulationUS 86859981.9y
- Aug 30, 2028formulationUS 86859981.9y
- Aug 30, 2028formulationUS 86859981.9y
- May 30, 2028formulationUS 101661901.7y
- May 30, 2028formulationUS 101661901.7y
- May 30, 2028formulationUS 101661901.7y
- May 30, 2028method-of-use (U-2677)US 108641991.7y
- May 30, 2028method-of-use (U-2678)US 108641991.7y
- May 30, 2028method-of-use (U-2678)US 108641991.7y
- May 30, 2028method-of-use (U-2678)US 111100811.7y
- May 30, 2028method-of-use (U-2678)US 111100811.7y
- May 30, 2028method-of-use (U-2678)US 111100811.7y
- May 30, 2028method-of-use (U-2677)US 111233311.7y
- May 30, 2028method-of-use (U-2677)US 111233311.7y
- May 30, 2028method-of-use (U-2677)US 111233311.7y
- May 30, 2028formulationUS 114198231.7y
- May 30, 2028formulationUS 114198231.7y
- May 30, 2028formulationUS 114198231.7y
- May 30, 2028method-of-use (U-2678)US 120831031.7y
- May 30, 2028method-of-use (U-2678)US 120831031.7y
- May 30, 2028method-of-use (U-2678)US 120831031.7y
- May 30, 2028formulationUS 124030951.7y
- May 30, 2028formulationUS 124030951.7y
- May 30, 2028formulationUS 124030951.7y
- May 30, 2028formulationUS 95499181.7y
- May 30, 2028formulationUS 95499181.7y
- May 30, 2028formulationUS 95499181.7y
FDA exclusivities (6)
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
- Jul 16, 2028ODE-360Orphan Drug (7y)1.8y
News(0)
no news has mentioned this drug yet
Data sources
last refreshed 1h ago
Found something off?
comments(0)
5-min edit window · permanent after that