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OJJAARA Drug Patent Profile

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

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

See drug prices for OJJAARA

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

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.

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.

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

International Patents for OJJAARA

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

Country	Patent Number	Title	Estimated Expiration
Japan	6883560
Eurasian Patent Organization	202190122	СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА, НЕ ЗАВИСЯЩИЕ ОТ КОЛИЧЕСТВА ТРОМБОЦИТОВ
Portugal	3154950

OJJAARA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ojjaara

Introduction to Ojjaara

Ojjaara, also known as momelotinib, is a Janus kinase (JAK) 1 and 2 and activin A receptor type I (ACVR1) inhibitor developed by GSK following its acquisition of Sierra Oncology in 2022 for $1.9 billion. This drug has been approved by the FDA to treat adult myelofibrosis patients with anaemia, marking a significant milestone in the treatment of this rare blood cancer[1][3].

Regulatory Approval and Market Impact

The FDA approval of Ojjaara is broader than initially expected, covering patients regardless of their previous treatment history. This makes it the first and only drug approved in the US to treat myelofibrosis patients with anaemia, providing a competitive edge over existing treatments[1][3].

Competitive Landscape

Ojjaara enters a market dominated by Incyte's blockbuster JAK inhibitor, Jakafi (ruxolitinib), which has been the market leader since its approval in 2011. Despite the presence of other JAK inhibitors like Bristol Myers Squibb's Inrebic (fedratinib) and CTI Biopharma's Vonjo (pacritinib), Jakafi remains the primary competitor. However, Ojjaara's unique profile, particularly its ability to address anaemia, a common complication in myelofibrosis patients, positions it as a strong challenger[1][3][4].

Clinical Differentiation

Ojjaara's clinical profile is differentiated by its ability to eliminate or reduce the need for frequent blood transfusions and achieve significant spleen and constitutional symptom control. The Momentum study, a phase III trial, confirmed these benefits, making Ojjaara an attractive option for patients with anaemia, a condition not adequately addressed by other myelofibrosis treatments[1][3].

Financial Performance and Projections

The approval of Ojjaara is expected to be a significant growth driver for GSK's oncology segment. In 2022, GSK's total oncology sales were $744 million, projected to rise above $1.5 billion by 2027. The broader-than-expected approval for Ojjaara is anticipated to further boost these sales figures[1].

In the Q3 2024 results, GSK reported strong performance in Specialty Medicines, with oncology sales increasing by 94%. This growth is attributed to the strong uptake of Ojjaara, among other factors. GSK's chief commercial officer, Luke Miels, noted that Ojjaara had reached 750 patients, making up 15% of the patient share in the anemic population, and about 25% share in second-line treatment[2][4].

Market Share and Competition

Despite the strong launch of Ojjaara, Incyte's Jakafi maintained a significant market share. According to Incyte, Jakafi retained around 53-54% of the total myelofibrosis market share and 60-63% of new patient share from September to December 2023. However, analysts believe that Ojjaara's approval could put pressure on Jakafi sales, especially given that about 40% of myelofibrosis patients exhibit anaemia symptoms at diagnosis[4].

Future Growth Prospects

GSK plans to explore combinations of Ojjaara with different inhibitors, such as bromodomain and extra-terminal inhibitors, and to pursue further haematological indications. This strategic expansion could further enhance Ojjaara's market presence and contribute to GSK's growing oncology segment[1].

Intellectual Property and Patent Protection

Momelotinib's composition patents are set to expire between 2028-2030, although a salt form is protected until 2035. This timeline could impact the long-term market exclusivity of Ojjaara, but it does not immediately threaten its current market position[3].

Impact on GSK’s Oncology Segment

The approval of Ojjaara strengthens GSK's oncology segment, one of its priority therapeutic areas. GSK's oncology pipeline is robust, with four oncological assets in phase III studies across seven indications. The success of Ojjaara aligns with GSK's strategic focus on oncology, following significant investments such as the $5.1 billion acquisition of TESARO in 2019[1][2].

Key Takeaways

• Broad FDA Approval: Ojjaara is the first and only drug approved in the US to treat myelofibrosis patients with anaemia.
• Competitive Edge: Its ability to address anaemia provides a competitive advantage over existing treatments like Jakafi.
• Financial Growth: Expected to be a significant growth driver for GSK's oncology segment, with projected sales above $1.5 billion by 2027.
• Market Share: Despite strong competition from Jakafi, Ojjaara has made a notable impact in the market, capturing a significant patient share.
• Future Prospects: Plans for combination therapies and additional haematological indications could further boost Ojjaara's market presence.

FAQs

Q: What is Ojjaara and how is it used? A: Ojjaara (momelotinib) is a JAK 1 and 2 and ACVR1 inhibitor used to treat adult myelofibrosis patients with anaemia.

Q: How does Ojjaara differ from other myelofibrosis treatments? A: Ojjaara is the first drug approved to specifically address anaemia in myelofibrosis patients, providing a unique therapeutic benefit.

Q: What is the competitive landscape for Ojjaara? A: Ojjaara competes primarily with Incyte's Jakafi, but its broad anaemia indication gives it a competitive edge.

Q: How has the market responded to Ojjaara's launch? A: Ojjaara has seen strong uptake, capturing 15% of the patient share in the anemic population and 25% in second-line treatment.

Q: What are the future growth prospects for Ojjaara? A: GSK plans to explore combination therapies and additional haematological indications, which could further boost Ojjaara's market presence.

Cited Sources

1. Fitch Solutions: "GSK's Sierra Acquisition Pays Off With Latest JAK Inhibitor Approval" - September 19, 2023.
2. GSK: "Q3 2024 Results Announcement" - October 29, 2024.
3. Oncology Pipeline: "12 years on, Jakafi faces serious JAK competition" - September 18, 2023.
4. FiercePharma: "Amid GSK showdown, Incyte crosses $1B in quarterly revenue" - February 13, 2024.