Trial	Phase	Status	Sponsor	Enrollment	Dates
Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome NCT00044304	Phase 2	Active	National Institute of Allergy and Infectious Diseases (NIAID)	70	2002-09-26 → 2027-03-10
Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older NCT02494882	Phase 1	Active	Memorial Sloan Kettering Cancer Center	12	2015-06-29 → 2027-06
Ruxolitinib + Allogeneic Stem Cell Transplantation in AML NCT03286530	Phase 2	Active	Massachusetts General Hospital	64	2017-11-03 → 2026-12
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)NCT04603495	Phase 3	Active	Novartis Pharmaceuticals	430	2021-04-09 → 2027-06-30
Enhanced 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 Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm NCT04041050	Phase 1	Active	AbbVie	85	2019-11-08 → 2026-12-31
Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)NCT03674047	Phase 2	Active	Massachusetts General Hospital	50	2019-04-19 → 2025-12
Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors NCT03610971	Phase 2	Active	H. Lee Moffitt Cancer Center and Research Institute	24	2019-11-19 → 2026-10
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis NCT03165734	Phase 3	Active	Swedish Orphan Biovitrum	407	2017-06-26 → 2028-10-13
Ruxolitinib for Cancer Cachexia NCT04906746	Early Phase 1	Active	Tu Dan	10	2022-02-23 → 2026-09

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 22, 2026	SUPPL -1	View Letter (PDF)
May 4, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 11MG BASE

RLD

17 patents3 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 1, 2026

Patents (17) · 36 use codes

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	—	—
8530485	Dec 12, 2026	—	—	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, 2026	—	—	—		—
9206187	Dec 12, 2026	—	—	—		—
9814722	Dec 12, 2026	—	—	—		—
10016429	Jun 12, 2028PED: Dec 12, 2028	PED	—	—		—
10874616	Nov 14, 2033PED: May 14, 2034	PED	—	Yes	—	—
11213528	Jun 12, 2028PED: Dec 12, 2028	PED	—	Yes	—	—
11337927	Jan 17, 2034PED: Jul 17, 2034	PED	—	—		—
11576864	Nov 14, 2033PED: May 14, 2034	PED	—	—		—
11576865	Nov 14, 2033PED: May 14, 2034	PED	—	Yes		—
11744832	Dec 12, 2026	—	—	—		—
11896717	Nov 14, 2033PED: May 14, 2034	PED	—	Yes		—

Exclusivities (3)

Code	Date	Status
ODE*	Sep 22, 2028	Active
PED	Mar 22, 2029	Active
ODE**PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 22, 2029	Active

#002 — EQ 22MG BASE

RLD

17 patents3 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 1, 2026

#003 — EQ 33MG BASE

RLD

17 patents3 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 1, 2026

#004 — EQ 44MG BASE

RLD

17 patents3 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 1, 2026

#005 — EQ 55MG BASE

RLD

17 patents3 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 1, 2026

Change History (5)

Recent changes detected for this application.

ADDED8/31/2026

JAKAFI XR (ruxolitinib phosphate) gained Orphan Drug Exclusivity with expiration in Mar 2029.

New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029

ADDED8/31/2026

JAKAFI XR (ruxolitinib phosphate) received orphan drug exclusivity with expiration of Mar 2029.

New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029

ADDED8/31/2026

JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029.

New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029

ADDED8/31/2026

Incyte's JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity, with protection expiring in Mar 2029.

New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029

ADDED8/31/2026

JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029 under supplemental application 217180-005.

New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029