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OJJAARA Drug Patent Profile

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When do Ojjaara patents expire, and when can generic versions of Ojjaara launch?

Ojjaara is a drug marketed by Glaxosmithkline and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and three patent family members in thirty-five countries.

The generic ingredient in OJJAARA is momelotinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the momelotinib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ojjaara

Ojjaara will be eligible for patent challenges on September 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 15, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OJJAARA

International Patents:	103
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for OJJAARA
What excipients (inactive ingredients) are in OJJAARA?	OJJAARA excipients list
DailyMed Link:	OJJAARA at DailyMed

Drug patent expirations by year for OJJAARA

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

Generic Entry Date for OJJAARA^: ⤷ 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 NDA: 216873 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 OJJAARA

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

Sponsor	Phase
Karyopharm Therapeutics Inc	Phase 2

See all OJJAARA clinical trials

Pharmacology for OJJAARA

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

US Patents and Regulatory Information for OJJAARA

OJJAARA is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OJJAARA is ⤷ Sign Up.

This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OJJAARA

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS IN SUBJECTS HAVING A BASELINE PLATELET COUNT OF LESS THAN 50 BILLION/L

Phenyl amino pyrimidine compounds and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS

(N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS

FDA Regulatory Exclusivity protecting OJJAARA

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
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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

See the table below for patents covering OJJAARA around the world.

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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