MOMELOTINIB DIHYDROCHLORIDE - Generic Drug Details

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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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Momelotinib dihydrochloride has one hundred and three patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for MOMELOTINIB DIHYDROCHLORIDE

International Patents:	103
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	17
Patent Applications:	20
DailyMed Link:	MOMELOTINIB DIHYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MOMELOTINIB DIHYDROCHLORIDE

Generic Entry Date for MOMELOTINIB DIHYDROCHLORIDE^: ⤷ Sign Up* 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
Karyopharm Therapeutics Inc	Phase 2
PSI CRO	Phase 3
Covance	Phase 3

See all MOMELOTINIB DIHYDROCHLORIDE clinical trials

Pharmacology for MOMELOTINIB DIHYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Kinase Inhibitors

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

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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
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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 MOMELOTINIB DIHYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Lithuania	3154950		⤷ Sign Up
Brazil	122020010759	compostos de fenil amino pirimidina inibidores de proteína quinases, processo para a preparação do composto, composição farmacêutica, e, implante	⤷ Sign Up
Cuba	20160183	SALES DEL CLORHIDRATO DE N-(CIANOMETIL)-4-(2-(4-MORFOLINOFENILAMINO)PIRIMIDIN-4-IL)BENZAMIDA	⤷ Sign Up
Canada	2702650	COMPOSES DE PHENYLAMINO PYRIMIDINE ET UTILISATIONS DE CES DERNIERS (PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF)	⤷ Sign Up
Spain	2822773		⤷ Sign Up
Taiwan	202012378	N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide	⤷ Sign Up
Japan	2014114311	PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.