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Envarsus XR · pharmadog

pharmadog
drugs
Envarsus XR

drug

patient view →

tacrolimus ER

Marketedupdated 2mo ago

by Veloxis Pharmaceuticals Inc

Approved

community 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

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

TACROLIMUS — FDA approval

view all 8 catalysts →

News(0)

no news has mentioned this drug yet

brand

Envarsus XR

generic

tacrolimus

MOA

FK506-binding protein 1A inhibitor

indication

Kidney Transplant Rejection

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed just now

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Patent cliff

source: FDA Orange Book

first barrier falls

May 30, 2028

~1.9 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 86642392.2y
Aug 30, 2028method-of-use (U-2678)US 86642392.2y
Aug 30, 2028method-of-use (U-2678)US 86642392.2y
Aug 30, 2028formulationUS 86859982.2y
Aug 30, 2028formulationUS 86859982.2y
Aug 30, 2028formulationUS 86859982.2y
May 30, 2028formulationUS 101661901.9y
May 30, 2028formulationUS 101661901.9y
May 30, 2028formulationUS 101661901.9y
May 30, 2028method-of-use (U-2677)US 108641991.9y
May 30, 2028method-of-use (U-2678)US 108641991.9y
May 30, 2028method-of-use (U-2678)US 108641991.9y
May 30, 2028method-of-use (U-2678)US 111100811.9y
May 30, 2028method-of-use (U-2678)US 111100811.9y
May 30, 2028method-of-use (U-2678)US 111100811.9y
May 30, 2028method-of-use (U-2677)US 111233311.9y
May 30, 2028method-of-use (U-2677)US 111233311.9y
May 30, 2028method-of-use (U-2677)US 111233311.9y
May 30, 2028formulationUS 114198231.9y
May 30, 2028formulationUS 114198231.9y
May 30, 2028formulationUS 114198231.9y
May 30, 2028method-of-use (U-2678)US 120831031.9y
May 30, 2028method-of-use (U-2678)US 120831031.9y
May 30, 2028method-of-use (U-2678)US 120831031.9y
May 30, 2028formulationUS 124030951.9y
May 30, 2028formulationUS 124030951.9y
May 30, 2028formulationUS 124030951.9y
May 30, 2028formulationUS 95499181.9y
May 30, 2028formulationUS 95499181.9y
May 30, 2028formulationUS 95499181.9y

FDA exclusivities (6)

Jul 16, 2028ODE-360Orphan Drug (7y)2.0y
Jul 16, 2028ODE-360Orphan Drug (7y)2.0y
Jul 16, 2028ODE-360Orphan Drug (7y)2.0y
Jul 16, 2028ODE-360Orphan Drug (7y)2.0y
Jul 16, 2028ODE-360Orphan Drug (7y)2.0y
Jul 16, 2028ODE-360Orphan Drug (7y)2.0y

Trials studying tacrolimus ER

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 Inhibitorrecruitingn=636
phase3A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)recruitingn=180
phase2Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitisrecruitingn=20
phase3A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantationrecruitingn=526
phase2Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinibactive not recruitingn=305
phase2Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantationactive not recruitingn=60
phase3Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)recruitingn=176
phase1Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantationnot yet recruitingn=40

more trials →