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  1. pharmadog
  2. ›drugs
  3. ›Opzelura
drug · small molecule
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Opzelura

Marketedupdated 5mo ago
by $INCY INCYTE CORP🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 6 investigational indications.

targets

Tyrosine-protein kinase JAK1Tyrosine-protein kinase JAK2

all catalysts(0)

nothing on the calendar yet

Trials studying Opzelura

  • phase2A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosisactive not recruitingn=33
  • phase3A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosisrecruitingn=105
  • phase1A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.completedn=476

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 24, 2026
53 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (112)

  • May 5, 2041method-of-use (U-3550)US 11602536
  • Sep 4, 2040method-of-use (U-3505)US 11510923
  • Sep 4, 2040method-of-use (U-3505)US 11590137
  • Jul 28, 2040method-of-use (U-4151)US 12233067
  • Jun 10, 2040method-of-use (U-3551)US 11590138
  • Nov 20, 2031patentUS 10758543*PED
  • Nov 20, 2031patentUS 10869870*PED
  • Nov 20, 2031patentUS 11219624*PED
  • May 20, 2031formulationUS 107585434.6y
  • May 20, 2031method-of-use (U-3229)US 108698704.6y
  • May 20, 2031formulationUS 112196244.6y
  • May 20, 2031formulationUS 115714254.6y
  • May 20, 2031method-of-use (U-3404)US 115901364.6y
  • May 20, 2031formulationUS 122264194.6y
  • May 20, 2031formulationUS 125443814.6y
  • May 20, 2031formulationUS 125645934.6y
  • Dec 12, 2028patentUS 10016429*PED2.2y
  • Dec 12, 2028patentUS 10016429*PED2.2y
  • Dec 12, 2028patentUS 10016429*PED2.2y
  • Dec 12, 2028patentUS 10016429*PED2.2y
  • Dec 12, 2028patentUS 10016429*PED2.2y
  • Dec 12, 2028patentUS 10610530*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8722693*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8822481*PED2.2y
  • Dec 12, 2028patentUS 8829013*PED2.2y
  • Dec 12, 2028patentUS 8829013*PED2.2y
  • Dec 12, 2028patentUS 8829013*PED2.2y
  • Dec 12, 2028patentUS 8829013*PED2.2y
  • Dec 12, 2028patentUS 8829013*PED2.2y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 7598257*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 24, 2028patentUS 8415362*PED1.7y
  • Jun 12, 2028method-of-use (U-3230)US 100164291.7y
  • Jun 12, 2028method-of-use (U-3230)US 100164291.7y
  • Jun 12, 2028method-of-use (U-3230)US 100164291.7y
  • Jun 12, 2028method-of-use (U-3230)US 100164291.7y
  • Jun 12, 2028method-of-use (U-3230)US 100164291.7y
  • Jun 12, 2028method-of-use (U-3229)US 106105301.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028compositionUS 87226931.7y
  • Jun 12, 2028method-of-use (U-3229)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3230)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3230)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3230)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3230)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3230)US 88224811.7y
  • Jun 12, 2028method-of-use (U-3228)US 88290131.7y
  • Jun 12, 2028method-of-use (U-3227)US 88290131.7y
  • Jun 12, 2028method-of-use (U-3227)US 88290131.7y
  • Jun 12, 2028method-of-use (U-3227)US 88290131.7y
  • Jun 12, 2028method-of-use (U-3228)US 88290131.7y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 75982571.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Dec 24, 2027compositionUS 84153621.2y
  • Jun 12, 2027patentUS 10639310*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9079912*PED253d
  • Jun 12, 2027patentUS 9814722*PED253d
  • Jun 12, 2027patentUS 9814722*PED253d
  • Jun 12, 2027patentUS 9814722*PED253d
  • Jun 12, 2027patentUS 9814722*PED253d
  • Jun 12, 2027patentUS 9814722*PED253d
  • Jun 12, 2027patentUS 9974790*PED253d
  • Dec 12, 2026method-of-use (U-3229)US 1063931071d
  • Dec 12, 2026method-of-use (U-3230)US 907991271d
  • Dec 12, 2026method-of-use (U-3230)US 907991271d
  • Dec 12, 2026method-of-use (U-3230)US 907991271d
  • Dec 12, 2026method-of-use (U-3230)US 907991271d
  • Dec 12, 2026method-of-use (U-3230)US 907991271d
  • Dec 12, 2026method-of-use (U-3229)US 907991271d
  • Dec 12, 2026method-of-use (U-3230)US 981472271d
  • Dec 12, 2026method-of-use (U-3230)US 981472271d
  • Dec 12, 2026method-of-use (U-3230)US 981472271d
  • Dec 12, 2026method-of-use (U-3230)US 981472271d
  • Dec 12, 2026method-of-use (U-3230)US 981472271d
  • Dec 12, 2026method-of-use (U-3229)US 997479071d

FDA exclusivities (33)

  • Mar 22, 2029PEDPediatric (6mo bonus)2.5y
  • Mar 22, 2029PEDPediatric (6mo bonus)2.5y
  • Mar 22, 2029PEDPediatric (6mo bonus)2.5y
  • Mar 22, 2029PEDPediatric (6mo bonus)2.5y
  • Mar 22, 2029PEDPediatric (6mo bonus)2.5y
  • Sep 22, 2028ODE-373Orphan Drug (7y)2.0y
  • Sep 22, 2028ODE-373Orphan Drug (7y)2.0y
  • Sep 22, 2028ODE-373Orphan Drug (7y)2.0y
  • Sep 22, 2028ODE-373Orphan Drug (7y)2.0y
  • Sep 22, 2028ODE-373Orphan Drug (7y)2.0y
  • Sep 18, 2028NPPNew Product (3y)2.0y
  • Nov 24, 2026PEDPediatric (6mo bonus)53d
  • Nov 24, 2026PEDPediatric (6mo bonus)53d
  • Nov 24, 2026PEDPediatric (6mo bonus)53d
  • Nov 24, 2026PEDPediatric (6mo bonus)53d
  • Nov 24, 2026PEDPediatric (6mo bonus)53d
  • Jun 19, 2026PEDPediatric (6mo bonus)
  • Jun 19, 2026PEDPediatric (6mo bonus)
  • Jun 19, 2026PEDPediatric (6mo bonus)
  • Jun 19, 2026PEDPediatric (6mo bonus)
  • Jun 19, 2026PEDPediatric (6mo bonus)
  • May 24, 2026ODE-238Orphan Drug (7y)
  • May 24, 2026ODE-238Orphan Drug (7y)
  • May 24, 2026ODE-238Orphan Drug (7y)
  • May 24, 2026ODE-238Orphan Drug (7y)
  • May 24, 2026ODE-238Orphan Drug (7y)
  • Jan 18, 2026PEDPediatric (6mo bonus)
  • Dec 19, 2025M-285Method (3y)
  • Dec 19, 2025M-285Method (3y)
  • Dec 19, 2025M-285Method (3y)
  • Dec 19, 2025M-285Method (3y)
  • Dec 19, 2025M-285Method (3y)
  • Jul 18, 2025I-896Indication (3y)

News(10)

  • Mid-cap biotechs join Trump’s latest round of drug pricing deals
    Focused on Medicaid, the new pacts now involve more than just large pharmaceutical companies, but still aren’t expected to meaningfully impact drugmaker profits.
    biopharma_dive · 1mo ago
  • 9 midsize drugmakers climb aboard Trump’s MFN train
    Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program…
    biospace · 1mo ago
  • FDA OKs Takeda, Protagonist drug for rare blood cancer
    The clearance and broader-than-expected label for Mimrylo open up a yearly revenue opportunity for Takeda that some analysts expect to reach $2 billion or more.
    biopharma_dive · 1mo ago
  • Incyte cuts early-stage cancer drug to focus on next-gen programs
    Investors are focused on Incyte’s late-stage programs as the biotech braces for the 2028 patent cliff of its leading product Jakafi.
    biospace · 2mo ago
  • Incyte ditches phase 1-stage JAK inhibitor to pursue next-gen options
    Incyte has ditched a JAK2 inhibitor in phase 1 development for a rare blood cancer in favor of “next-generation” replacements.
    fiercebiotech · 2mo ago
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.
    fiercebiotech · 2mo ago
  • On second try, Acadia drug gets nod from European regulators
    The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.
    biopharma_dive · 3mo ago
  • Lilly scores early positive data for new JAK drug
    Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
    biopharma_dive · 3mo ago
  • Incyte CEO sees $2B Vega deal aiding a post-Jakafi future
    Bill Meury has been in or led the C-suite of several biopharma companies that have constructed multibillion-dollar exits over the past decade: Allergan, Karuna and Anthos. Now, he’s the one buying.…
    endpoints · 3mo ago
  • Incyte to buy blood disorder drug in possibly $2B deal
    Acquiring Vega Therapeutics, an offshoot of "hub-and-spoke" biotech Star Therapeutics, would give Incyte a medicine that’s in late-stage testing and designed to control bleeding.
    biopharma_dive · 3mo ago
view all news mentions →
brand
Opzelura
trade names
Jakafi, Jakavi, Opzelura
generic
ruxolitinib phosphate
MOA
Tyrosine-protein kinase JAK1 inhibitor; Tyrosine-protein kinase JAK2 inhibitor
indication
Hidradenitis Suppurativa
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 3h ago
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