drug · small molecule

Opzelura

Marketedupdated 3mo 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

104 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 107585434.8y
May 20, 2031method-of-use (U-3229)US 108698704.8y
May 20, 2031formulationUS 112196244.8y
May 20, 2031formulationUS 115714254.8y
May 20, 2031method-of-use (U-3404)US 115901364.8y
May 20, 2031formulationUS 122264194.8y
May 20, 2031formulationUS 125443814.8y
May 20, 2031formulationUS 125645934.8y
Dec 12, 2028patentUS 10016429*PED2.3y
Dec 12, 2028patentUS 10016429*PED2.3y
Dec 12, 2028patentUS 10016429*PED2.3y
Dec 12, 2028patentUS 10016429*PED2.3y
Dec 12, 2028patentUS 10016429*PED2.3y
Dec 12, 2028patentUS 10610530*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8722693*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8822481*PED2.3y
Dec 12, 2028patentUS 8829013*PED2.3y
Dec 12, 2028patentUS 8829013*PED2.3y
Dec 12, 2028patentUS 8829013*PED2.3y
Dec 12, 2028patentUS 8829013*PED2.3y
Dec 12, 2028patentUS 8829013*PED2.3y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 7598257*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 24, 2028patentUS 8415362*PED1.9y
Jun 12, 2028method-of-use (U-3230)US 100164291.8y
Jun 12, 2028method-of-use (U-3230)US 100164291.8y
Jun 12, 2028method-of-use (U-3230)US 100164291.8y
Jun 12, 2028method-of-use (U-3230)US 100164291.8y
Jun 12, 2028method-of-use (U-3230)US 100164291.8y
Jun 12, 2028method-of-use (U-3229)US 106105301.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028compositionUS 87226931.8y
Jun 12, 2028method-of-use (U-3229)US 88224811.8y
Jun 12, 2028method-of-use (U-3230)US 88224811.8y
Jun 12, 2028method-of-use (U-3230)US 88224811.8y
Jun 12, 2028method-of-use (U-3230)US 88224811.8y
Jun 12, 2028method-of-use (U-3230)US 88224811.8y
Jun 12, 2028method-of-use (U-3230)US 88224811.8y
Jun 12, 2028method-of-use (U-3228)US 88290131.8y
Jun 12, 2028method-of-use (U-3227)US 88290131.8y
Jun 12, 2028method-of-use (U-3227)US 88290131.8y
Jun 12, 2028method-of-use (U-3227)US 88290131.8y
Jun 12, 2028method-of-use (U-3228)US 88290131.8y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 75982571.4y
Dec 24, 2027compositionUS 84153621.4y
Dec 24, 2027compositionUS 84153621.4y
Dec 24, 2027compositionUS 84153621.4y
Dec 24, 2027compositionUS 84153621.4y
Dec 24, 2027compositionUS 84153621.4y
Dec 24, 2027compositionUS 84153621.4y
Jun 12, 2027patentUS 10639310*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9079912*PED304d
Jun 12, 2027patentUS 9814722*PED304d
Jun 12, 2027patentUS 9814722*PED304d
Jun 12, 2027patentUS 9814722*PED304d
Jun 12, 2027patentUS 9814722*PED304d
Jun 12, 2027patentUS 9814722*PED304d
Jun 12, 2027patentUS 9974790*PED304d
Dec 12, 2026method-of-use (U-3229)US 10639310122d
Dec 12, 2026method-of-use (U-3230)US 9079912122d
Dec 12, 2026method-of-use (U-3230)US 9079912122d
Dec 12, 2026method-of-use (U-3230)US 9079912122d
Dec 12, 2026method-of-use (U-3230)US 9079912122d
Dec 12, 2026method-of-use (U-3230)US 9079912122d
Dec 12, 2026method-of-use (U-3229)US 9079912122d
Dec 12, 2026method-of-use (U-3230)US 9814722122d
Dec 12, 2026method-of-use (U-3230)US 9814722122d
Dec 12, 2026method-of-use (U-3230)US 9814722122d
Dec 12, 2026method-of-use (U-3230)US 9814722122d
Dec 12, 2026method-of-use (U-3230)US 9814722122d
Dec 12, 2026method-of-use (U-3229)US 9974790122d

FDA exclusivities (33)

Mar 22, 2029PEDPediatric (6mo bonus)2.6y
Mar 22, 2029PEDPediatric (6mo bonus)2.6y
Mar 22, 2029PEDPediatric (6mo bonus)2.6y
Mar 22, 2029PEDPediatric (6mo bonus)2.6y
Mar 22, 2029PEDPediatric (6mo bonus)2.6y
Sep 22, 2028ODE-373Orphan Drug (7y)2.1y
Sep 22, 2028ODE-373Orphan Drug (7y)2.1y
Sep 22, 2028ODE-373Orphan Drug (7y)2.1y
Sep 22, 2028ODE-373Orphan Drug (7y)2.1y
Sep 22, 2028ODE-373Orphan Drug (7y)2.1y
Sep 18, 2028NPPNew Product (3y)2.1y
Nov 24, 2026PEDPediatric (6mo bonus)104d
Nov 24, 2026PEDPediatric (6mo bonus)104d
Nov 24, 2026PEDPediatric (6mo bonus)104d
Nov 24, 2026PEDPediatric (6mo bonus)104d
Nov 24, 2026PEDPediatric (6mo bonus)104d
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)

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 · 13d 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 · 14d 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 · 26d 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 · 1mo 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 · 1mo 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 · 2mo 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 · 2mo ago
Five Under 5: Top Oncology Videos for the Week of 5/3
The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.
onclive · 3mo ago
Dr Kuykendall on the Evolving JAK Inhibitor and Transplant Considerations in Myelofibrosis
Andrew Kuykendall, MD, explains considerations for JAK inhibitor sequencing and the use of transplant in myelofibrosis.
onclive · 3mo ago
Lilly to buy startup Ajax in bid for a better JAK drug
Worth up to $2.3 billion overall, the deal hands Lilly a drug designed to address the weaknesses of a class of medicines used to treat myelofibrosis and other diseases.
biopharma_dive · 3mo ago

view all news mentions →

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 48m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

News(10)

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 · 13d 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 · 14d 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 · 26d 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 · 1mo 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 · 1mo 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 · 2mo 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 · 2mo ago

Five Under 5: Top Oncology Videos for the Week of 5/3

The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.

onclive · 3mo ago

Dr Kuykendall on the Evolving JAK Inhibitor and Transplant Considerations in Myelofibrosis

Andrew Kuykendall, MD, explains considerations for JAK inhibitor sequencing and the use of transplant in myelofibrosis.

onclive · 3mo ago

Lilly to buy startup Ajax in bid for a better JAK drug

Worth up to $2.3 billion overall, the deal hands Lilly a drug designed to address the weaknesses of a class of medicines used to treat myelofibrosis and other diseases.

biopharma_dive · 3mo ago

view all news mentions →

Opzelura

targets

all catalysts(0)

Trials studying Opzelura

Patent cliff

patents (112)

FDA exclusivities (33)

News(10)

Report a data issue

comments(0)

Opzelura

targets

all catalysts(0)

Trials studying Opzelura

Patent cliff

patents (112)

FDA exclusivities (33)

News(10)

Report a data issue

comments(0)