Ruxolitinib phosphate - Generic Drug Details

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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:	27
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

Generic Entry Dates for ruxolitinib phosphate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for ruxolitinib phosphate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
City of Hope Medical Center	Phase 2
Zhengzhou University	Phase 4
Philipps University Marburg Medical 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

Anatomical Therapeutic Chemical (ATC) Classes for ruxolitinib phosphate

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ruxolitinib phosphate

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Country	Patent Number	Title	Estimated Expiration
Croatia	P20190385		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007070514		⤷ Sign Up
Taiwan	I499421		⤷ Sign Up
Taiwan	201704235	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as JANUS KINASE inhibitors	⤷ Sign Up
Japan	2023002758	ＪＡＫ阻害剤の局所製剤	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ruxolitinib phosphate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	PA2013002	Lithuania	⤷ Sign Up
1966202	CR 2013 00005	Denmark	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823
2455382	122017000020	Germany	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
1966202	PA2013002,C1966202	Lithuania	⤷ Sign Up	PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
1966202	1390005-5	Sweden	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/12/773/001; 2012-08-23; PERIOD OF VALIDITY (FROM - UNTIL): 2026-12-13 - 2027-08-27
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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