NIROGACESTAT HYDROBROMIDE - Generic Drug Details

What are the generic drug sources for nirogacestat hydrobromide and what is the scope of freedom to operate?

Nirogacestat hydrobromide is the generic ingredient in one branded drug marketed by Springworks and is included in one NDA. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nirogacestat hydrobromide has one hundred and four patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for NIROGACESTAT HYDROBROMIDE

International Patents:	104
US Patents:	26
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3
DailyMed Link:	NIROGACESTAT HYDROBROMIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT

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.

US Patents and Regulatory Information for NIROGACESTAT HYDROBROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		RX	Yes	No	11,844,780		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,925,620
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	10,710,966			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	11,807,611		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes

International Patents for NIROGACESTAT HYDROBROMIDE

Country	Patent Number	Title	Estimated Expiration
Canada	3150424	FORMES A L'ETAT SOLIDE DE (S)-2-(((S)-6,8-DIFLUORO-1,2,3,4-TETRAHYDRONAPHTHALEN-2-YL)AMINO)-N-(1-(2-METHYL-1-(NEOPENTYLAMINO)PROPAN-2-YL)-1H-IMIDAZOL-4-YL)PENTANAMIDE ET UTILISATI ONS ASSOSIEES (SOLID STATE FORMS OF (S)-2-(((S)-6,8-DIFLUORO-1,2,3,4-TETRAHYDRONAPHTHALEN-2-YL)AMINO)-N-(1-(2-METHYL-1-(NEOPENTYLAMINO)PROPAN-2-YL)-1H-IMIDAZOL-4-YL)PENTANAMIDE AND USES THEREOF)
Argentina	126961	SINTESIS DE NIROGACESTAT
World Intellectual Property Organization (WIPO)	2023039475
European Patent Office	4399203
Honduras	2005000115	COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS
Australia	2022380837

NIROGACESTAT HYDROBROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nirogacestat Hydrobromide

Introduction to Nirogacestat Hydrobromide

Nirogacestat hydrobromide, developed by SpringWorks Therapeutics, is a selective gamma-secretase inhibitor (GSI) that has garnered significant attention for its potential in treating various types of tumors, particularly desmoid tumors and aggressive fibromatosis. Here, we delve into the market dynamics and financial trajectory of this promising drug.

Therapeutic Indications and Mechanism of Action

Nirogacestat hydrobromide is primarily under development for the treatment of pediatric and adult desmoid tumors or aggressive fibromatosis. It also has potential applications in treating relapsed/refractory multiple myeloma, ovarian granulosa tumors, and soft tissue sarcoma. The drug works by inhibiting the gamma-secretase complex, which is crucial for the Notch signaling pathway. This inhibition can lead to the induction of apoptosis in tumor cells that overexpress Notch receptors[4].

Market Approval and Regulatory Status

Nirogacestat has received several significant regulatory designations, including Orphan Drug Designation from the U.S. FDA for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. It has also been granted Fast Track and Breakthrough Therapy Designations by the FDA for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis[4].

Commercial Performance

As of the third quarter of 2024, nirogacestat, marketed as OGSIVEO®, has shown strong commercial performance. SpringWorks Therapeutics reported $49.3 million in net product revenue for OGSIVEO in the third quarter, representing a 23% increase over the second quarter of 2024. This growth is indicative of the drug's increasing adoption, with over 800 unique desmoid tumor patients filling an OGSIVEO script in September 2024. Approximately 420 treatment centers have ordered OGSIVEO since its approval, and about 65% of patients are receiving the product in blister packages, which is expected to be fully transitioned by the end of the year[2].

Financial Results and Projections

SpringWorks Therapeutics' financial results reflect the growing success of OGSIVEO. The company reported a net loss of $53.5 million, or $0.72 per share, for the third quarter of 2024, which is a common scenario for biotech companies in the early stages of product launch. However, the company has a robust financial position with $498 million in cash, cash equivalents, and marketable securities as of September 30, 2024, which is expected to fund operations through profitability anticipated in the first half of 2026[2].

Research and Development Expenses

The increase in research and development (R&D) expenses is a significant factor in the financial trajectory of nirogacestat. For the third quarter of 2024, R&D expenses were $42.3 million, up from $37.5 million in the comparable period of 2023. This increase is primarily due to costs related to drug manufacturing, clinical trials, and other research activities[2].

Market Dynamics in Oncology

The oncology drugs market, within which nirogacestat operates, is experiencing rapid expansion. The global oncology drugs market is projected to grow from $231.56 billion in 2024 to $532.91 billion by 2031, with a CAGR of 12.6%. This growth is driven by the increasing prevalence of cancer and the rising demand for targeted therapies and immunotherapies. Targeted therapies, in particular, are expected to emerge as the largest segment by 2031, driven by their higher efficacy and reduced side effects[3].

Competitive Landscape

Nirogacestat operates in a competitive landscape dominated by major pharmaceutical companies such as Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, and Pfizer Inc. However, its unique mechanism of action and strong clinical data position it favorably in the market. SpringWorks Therapeutics' collaborations with industry-leading BCMA developers to evaluate nirogacestat in combination therapies further enhance its competitive edge[3][4].

Clinical Trials and Long-term Follow-Up Data

The Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors has provided promising long-term follow-up data. The trial highlights further reductions in tumor size, increased overall response rate (ORR), sustained improvement in desmoid tumor symptoms, and a consistent safety profile. These positive outcomes are crucial for the drug's continued market success and regulatory approvals[2].

Geographical Market

North America currently holds the largest share in the oncology drugs market, including nirogacestat, due to advanced treatment options and infrastructure. However, the Asia Pacific region is expected to witness the highest growth through 2031, driven by developing healthcare infrastructure and a growing patient population in countries like China and India[3].

Key Takeaways

• Strong Commercial Performance: OGSIVEO has shown significant revenue growth, with $49.3 million in net product revenue in the third quarter of 2024.
• Regulatory Approvals: Nirogacestat has received Orphan Drug Designation, Fast Track, and Breakthrough Therapy Designations.
• Financial Position: SpringWorks Therapeutics has a robust financial position to support operations through anticipated profitability in 2026.
• Market Growth: The oncology drugs market is projected to grow significantly, driven by targeted therapies.
• Competitive Edge: Nirogacestat's unique mechanism and strong clinical data position it favorably in the market.

FAQs

Q: What is the primary indication for nirogacestat hydrobromide?

A: Nirogacestat hydrobromide is primarily indicated for the treatment of pediatric and adult desmoid tumors or aggressive fibromatosis.

Q: What is the mechanism of action of nirogacestat hydrobromide?

A: Nirogacestat hydrobromide works by inhibiting the gamma-secretase complex, which is crucial for the Notch signaling pathway, leading to the induction of apoptosis in tumor cells.

Q: What are the recent financial highlights for OGSIVEO?

A: In the third quarter of 2024, OGSIVEO generated $49.3 million in net product revenue, representing a 23% increase over the second quarter of 2024.

Q: What is the current regulatory status of nirogacestat hydrobromide?

A: Nirogacestat has received Orphan Drug Designation, Fast Track, and Breakthrough Therapy Designations from the FDA and the European Commission.

Q: What are the projections for the oncology drugs market?

A: The global oncology drugs market is projected to grow from $231.56 billion in 2024 to $532.91 billion by 2031, with a CAGR of 12.6%.

Cited Sources

1. GlobalData: Net Present Value Model: Nirogacestat hydrobromide.
2. SpringWorks Therapeutics: SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights.
3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031.
4. New Drug Approvals: Nirogacestat.