Viewing data from:

JAKAFI

NDA

RUXOLITINIB PHOSPHATE | N202192 | INCYTE CORP

5 strengths8 unique patents4 unique exclusivities

Patent Timeline

8 unique patents, 3 exclusivities by expiration date

Expiring < 1yr (2)Active (6)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

Today

Jun. 24, 2028

Jun. 24, 2028

Dec. 12, 2028

Dec. 12, 2028

Dec. 12, 2028

Jun. 12, 2027

Jun. 12, 2027

Dec. 12, 2028

M-285

Nov. 24, 2026

ODE-238

Nov. 24, 2026

ODE-373

Nov. 24, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

9 cases on OB patents (4 active) from PACER

Case	Court	Filed	Status	Judge
INCYTE CORP. et al v. MSN PHARMACEUTICALS INC. et al 1:2026cv07949 6 patentsANDA 221086ruxolitinib	D.N.J.	2026-06-30	Active	—
INCYTE CORP. et al v. ALKEM LABORATORIES LTD. et al 1:2026cv02338 3 patentsANDA 221191ruxolitinib	D.N.J.	2026-03-05	Terminated 2026-06-03	—
INCYTE CORP. et al v. DR. REDDY'S LABORATORIES, INC. et al 1:2025cv17832 5 patentsANDA 220797ruxolitinib	D.N.J.	2025-11-21	Active	—
INCYTE CORP. et al v. EUGIA PHARMA SPECIALITIES LIMITED et al 1:2025cv17833 6 patentsANDA 220517ruxolitinib	D.N.J.	2025-11-21	Active	—
INCYTE CORP. et al v. SUN PHARMACEUTICAL INDUSTRIES, INC. et al 1:2025cv13225 4 patentsANDA 219852ruxolitinib	D.N.J.	2025-07-11	Active	—
INCYTE CORP. et al v. GRANULES INDIA LTD. 1:2025cv13227 5 patentsANDA 220521ruxolitinib	D.N.J.	2025-07-11	Terminated 2026-02-06	—
INCYTE CORP. et al v. APOTEX INC. 1:2025cv04044 5 patentsruxolitinib	D.N.J.	2025-05-08	Terminated 2025-11-12	—
INCYTE CORPORATION et al v. HIKMA PHARMACEUTICALS USA INC. 1:2025cv01859 5 patentsANDA 219768ruxolitinib	D.N.J.	2025-03-13	Terminated 2025-10-28	—
INCYTE CORPORATION et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2:2024cv06944 1 patentdeuruxolitinib (deuterated ruxolitinib)	D.N.J.	2024-06-11	Terminated 2025-07-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov — 7 recruiting, 3 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)NCT04509700	Phase 2	Active	Incyte Corporation	112	2020-08-03 → 2026-11-05
Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion NCT03722407	Phase 2	Active	H. Lee Moffitt Cancer Center and Research Institute	29	2019-08-28 → 2027-05-01
CINC424A2X01B Rollover Protocol NCT02386800	Phase 4	Active	Novartis Pharmaceuticals	279	2015-03-05 → 2032-04-05
Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study NCT07673640	—	Not Yet Recruiting	ShanShan Li	300	2026-06-20 → 2028-12-31
Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients NCT07597941	Phase 2/3	Not Yet Recruiting	The Affiliated People's Hospital of Ningbo University	20	2026-07 → 2028-12
Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)NCT07424222	Phase 1	Not Yet Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	16	2026-07-15 → 2029-02-01
Opzelura Experience Study NCT07661979	Phase 4	Not Yet Recruiting	Wake Forest University Health Sciences	50	2026-08 → 2027-10
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)NCT07357727	Phase 3	Recruiting	Novartis Pharmaceuticals	460	2026-05-27 → 2030-12-27
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata NCT05398809	Phase 2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	70	2023-01-18 → 2027-12-01
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors NCT06887803	Phase 1/2	Recruiting	iOnctura	26	2025-11-17 → 2028-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Jakafi (2023)

Total Spending

$1.9B

Total Claims

116,245

Beneficiaries

14,041

Avg Cost/Unit

$297.88

Spending Trend

$1.1B(2019)→$1.3B(2020)→$1.5B(2021)→$1.8B(2022)→$1.9B(2023)

YoY Change:+6.4%

5yr CAGR:+6.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs

14 active API suppliers hold Drug Master Files for this ingredient.

CHONGQING HUAPONT PHARMACEUTICAL CO LTDRUXOLITINIB PHOSPHATE

DMF 294802015

MSN LABORATORIES PRIVATE LTDRUXOLITINIB PHOSPHATE

DMF 322212017

CIPLA LTDRUXOLITINIB PHOSPHATE

DMF 385062023

DR REDDYS LABORATORIES LTDRUXOLITINIB

DMF 395462024

DR REDDYS LABORATORIES LTDRUXOLITINIB PHOSPHATE

DMF 397252024

CHANGZHOU PHARMACEUTICAL FACTORYRUXOLITINIB PHOSPHATE

DMF 397632024

MSN LABORATORIES PRIVATE LTDRUXOLITINIB PHOSPHATE

DMF 397892024

INTAS PHARMACEUTICALS LTDRUXOLITINIB PHOSPHATE

DMF 400662024

GRANULES INDIA LTDRUXOLITINIB PHOSPHATE

DMF 408742025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRUXOLITINIB PHOSPHATE

DMF 410122024

FLAVINE NORTH AMERICA INCRUXOLITINIB PHOSPHATE

DMF 412142025

ALIVUS LIFE SCIENCES LTDRUXOLITINIB PHOSPHATE

DMF 416202025

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDRUXOLITINIB PHOSPHATE

DMF 421192025

VALARY LAB PRIVATE LTDRUXOLITINIB PHOSPHATE

DMF 421422025

DEVI PHARMATECH PRIVATE LTDRUXOLITINIB PHOSPHATE

DMF 422862025

ALEMBIC PHARMACEUTICALS LTDRUXOLITINIB PHOSPHATE

DMF 423472025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Feb 1, 2023	SUPPL -28	View Letter (PDF)
Dec 21, 2022	SUPPL -27	View Letter (PDF)
Sep 30, 2021	SUPPL -23	View Letter (PDF)
Sep 28, 2021	SUPPL -25	View Letter (PDF)
Jan 23, 2020	SUPPL -19	View Letter (PDF)
Jun 4, 2019	SUPPL -17	View Letter (PDF)
Oct 29, 2018	SUPPL -16	View Letter (PDF)
Dec 12, 2017	SUPPL -15	View Letter (PDF)
Oct 12, 2017	SUPPL -14	View Letter (PDF)
Mar 14, 2016	SUPPL -12	View Letter (PDF)
Dec 16, 2014	SUPPL -9	View Letter (PDF)
Dec 5, 2014	SUPPL -8	View Letter (PDF)
Jul 28, 2014	SUPPL -6	View Letter (PDF)
Nov 27, 2013	SUPPL -5	View Letter (PDF)
Jun 13, 2013	SUPPL -3	View Letter (PDF)
Jun 25, 2012	SUPPL -1	View Letter (PDF)
Nov 16, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 5MG BASE

RLD

8 patents4 exclusivities▴

TABLET;ORAL | Approved: Nov 16, 2011

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7598257	Dec 24, 2027PED: Jun 24, 2028	PED	Yes	Yes		—
8415362	Dec 24, 2027PED: Jun 24, 2028	PED	Yes	Yes	—	—
8722693	Jun 12, 2028PED: Dec 12, 2028	PED	Yes	Yes	—	—
8822481	Jun 12, 2028PED: Dec 12, 2028	PED	—	—		—
8829013	Jun 12, 2028PED: Dec 12, 2028	PED	—	—		—
9079912	Dec 12, 2026PED: Jun 12, 2027	PED	—	—		—
9814722	Dec 12, 2026PED: Jun 12, 2027	PED	—	—		—
10016429	Jun 12, 2028PED: Dec 12, 2028	PED	—	—		—

Exclusivities (4)

Code	Date	Status
M-285	Dec 19, 2025	Expired
ODE-238	May 24, 2026	Expired
ODE-373	Sep 22, 2028	Active
PED	Nov 24, 2026	< 1 year

#002 — EQ 10MG BASE

RLD

8 patents4 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2011

#003 — EQ 15MG BASE

RLD

8 patents4 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2011

#004 — EQ 20MG BASE

RLD

8 patents4 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2011

#005 — EQ 25MG BASE

RLD

8 patents4 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2011