Momelotinib dihydrochloride - Generic Drug Details

What are the generic drug sources for momelotinib dihydrochloride and what is the scope of patent protection?

Momelotinib dihydrochloride is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Momelotinib dihydrochloride has eighty-nine patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for momelotinib dihydrochloride

International Patents:	89
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	16
Patent Applications:	20
DailyMed Link:	momelotinib dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for momelotinib dihydrochloride

Constraining patent/regulatory exclusivity:

TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA

Dosage:

TABLET;ORAL

^*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 momelotinib dihydrochloride

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

Sponsor	Phase
PSI CRO	Phase 3
Covance	Phase 3
CTI BioPharma	Phase 3

See all momelotinib dihydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for momelotinib dihydrochloride

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

US Patents and Regulatory Information for momelotinib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No

International Patents for momelotinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20150043565	페닐 아미노 피리미딘 화합물 및 이의 용도 (PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF)
Brazil	122020010759	compostos de fenil amino pirimidina inibidores de proteína quinases, processo para a preparação do composto, composição farmacêutica, e, implante
Singapore	10201911925T	N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE HYDROCHLORIDE SALTS
Portugal	3154950
Israel	249038	מלחי n-(ציאנומתיל)-4-(2-(4-מורפולינופנילאמינו)פירימידינ-4-יל)בנזאמיד הידרוכלוריד (N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide hydrochloride salts)
Japan	2013249316	PHENYLAMINOPYRIMIDINE COMPOUND AND USE THEREOF
Portugal	2152701