RUXOLITINIB PHOSPHATE - Generic Drug Details

What are the generic sources for ruxolitinib phosphate and what is the scope of freedom to operate?

Ruxolitinib phosphate is the generic ingredient in two branded drugs marketed by Incyte Corp and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ruxolitinib phosphate has three hundred and twenty-four patent family members in forty-eight countries.

There are two drug master file entries for ruxolitinib phosphate. One supplier is listed for this compound.

Summary for RUXOLITINIB PHOSPHATE

International Patents:	324
US Patents:	20
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	26
Patent Applications:	916
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUXOLITINIB PHOSPHATE
DailyMed Link:	RUXOLITINIB PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RUXOLITINIB PHOSPHATE

Dosage:

TABLET;ORAL

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RUXOLITINIB PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zhengzhou University	Phase 4
Philipps University Marburg Medical Center	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2

See all RUXOLITINIB PHOSPHATE clinical trials

Pharmacology for RUXOLITINIB PHOSPHATE

Drug Class	Janus Kinase Inhibitor Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPZELURA	Cream	ruxolitinib phosphate	1.5%	215309	1	2023-07-31
JAKAFI	Tablets	ruxolitinib phosphate	5 mg, 10 mg, 15 mg, 20 mg, and 25 mg	202192	1	2015-12-17

US Patents and Regulatory Information for RUXOLITINIB PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No

International Patents for RUXOLITINIB PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Denmark	2343299
Japan	6138865
Hong Kong	1168090	作為 激酶抑制劑的雜芳基取代的吡咯並 吡啶和吡咯並 嘧啶 (HETEROARYL SUBSTITUTED PYRROLO [2,3-B] PYRIDINES AND PYRROLO [2,3-B] PYRIMIDINES AS JANUS KINASE INHIBITORS JANUS [23-B][23-B])

Supplementary Protection Certificates for RUXOLITINIB PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2455382	132017000044713	Italy		PRODUCT NAME: RUXOLITINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(JAKAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/773/001-016, 20150313
1966202	C01966202/01	Switzerland		FORMER OWNER: INCYTE CORPORATION, US
1966202	PA2013002,C1966202	Lithuania		PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823