nirogacestat hydrobromide - Profile

What are the generic drug sources for nirogacestat hydrobromide and what is the scope of patent protection?

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

Nirogacestat hydrobromide has one hundred and forty-two patent family members in forty-eight countries.

Summary for nirogacestat hydrobromide

International Patents:	142
US Patents:	29
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nirogacestat hydrobromide

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

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		DISCN	Yes	No			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No				Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No				Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No				Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No

Expired US Patents for nirogacestat hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024

International Patents for nirogacestat hydrobromide

Country	Patent Number	Title	Estimated Expiration
Argentina	119614
Australia	2019461090
Australia	2022342176
Australia	2022380837
Australia	2023271953
Brazil	112022002392
Canada	3150424

Supplementary Protection Certificates for nirogacestat hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4010322	LUC50046	Luxembourg		PRODUCT NAME: FORME CRISTALLINE D'UN SEL D'HYDROBROMURE DE NIROGACESTAT, DE PREFERENCE UNE FORME CRISTALLINE DU SEL DE DIHYDROBROMURE DE NIROGACESTAT; AUTHORISATION NUMBER AND DATE: EU/1/25/1932 20250818
4010322	CA 2026 00017	Denmark		PRODUCT NAME: KRYSTALLINSK FORM AF ET HYDROBROMID SALT AF NIROGACESTAT, SAERLIGT EN KRYSTALLINSK FORM AF DIHYDROBROMID SALTET AF NIROGACESTAT; REG. NO/DATE: EU/1/25/1932 20250818
4010322	C20260011	Finland
4010322	PA2026516	Lithuania		PRODUCT NAME: OGSIVEO - NIROGACESTATAS; REGISTRATION NO/DATE: EU/1/25/1932 20250814
4010322	301374	Netherlands		PRODUCT NAME: KRISTALLIJNE VORM VAN EEN HYDROBROMIDEZOUT VAN NIROGACESTAT, BIJ VOORKEUR EEN KRISTALLIJNE VORM VAN HET DIHYDROBROMIDEZOUT VAN NIROGACESTAT; REGISTRATION NO/DATE: EU/1/25/1932 20250818

Investment Scenario and Fundamentals Analysis for Nirogacestat Hydrobromide

Last updated: February 19, 2026

What is Nirogacestat Hydrobromide?

Nirogacestat (formerly known as ABBV-621) is an oral, selective gamma-secretase inhibitor under development by Abbey V. It targets the Notch signaling pathway. This pathway influences cell differentiation, proliferation, and apoptosis and is implicated in various cancers and other proliferative diseases.

Development Status and Regulatory Pathway

Phase	Development Status	Key Milestones	Expected FDA/EMA Filing Dates
Phase 2	Completed	Demonstrated efficacy in desmoid tumors	Q3 2022 (FDA NDA submission rumored)
Phase 3	Ongoing	Trials for desmoid tumors, gliomas	Data readouts anticipated mid-2023 to 2024
Regulatory	Pending	Potential accelerated approval pathways	FDA and EMA review expected end of 2024

Nirogacestat has received Orphan Drug Designation for desmoid tumors, which may reduce development costs and expedite review. It has also attracted interest from biotech and pharma investors due to its promise in rare tumor indications.

Market Fundamentals

Indication Opportunities

• Desmoid tumors: Rare, non-metastatic fibrous neoplasms with an annual incidence of approximately 2–4 per million. US market size estimated around $300 million annually (EvaluatePharma, 2022).
• Gliomas (including glioblastoma): Larger market with over 12,000 new cases annually in the US. Market size projected at $500 million+ (GlobalData, 2022).
• Other potential indications: Alzheimer's, other solid tumors, due to gamma-secretase inhibition.

Competitive Landscape

Competitors	Focus	Development Stage	Market Share	Key Assets
Pfizer	Notch pathway inhibitors	Phase 1/2	Small	Limited pipeline in desmoid tumors
Deciphera	Tumor-targeted therapies	Multiple	Niche	Registrational assets in rare tumors
Novartis	Gamma-secretase inhibitors	Early	Limited	Broader pipeline in neurodegeneration

Nirogacestat’s specificity for gamma-secretase inhibition and orphan designation provide competitive advantages against broader, more toxic Notch inhibitors.

Commercial and Pricing Outlook

• Pricing: Orphan drugs for rare tumors price from $100,000 to $200,000 annually per patient.
• Uptake factors: Orphan designation, demonstrated efficacy, and manageable safety profile support pricing power.
• Market penetration: Slow uptake initially, potentially accelerating post-approval given unmet needs.

Financial and Investment Fundamentals

Cost and Investment Profile

• R&D costs for completing Phase 3 estimated at $200–$300 million, including trials, regulatory, and manufacturing.
• Potential licensing deals or partnership valuations could reach $1–$2 billion depending on success milestones.

Revenue Projections

Scenario	Peak Market Share	Annual Revenue (USD)	Timeline
Conservative	10% of US desmoid tumor market	$30 million	Year 5 post-approval
Aggressive	30% of global rare tumor market	$150 million	Year 7 post-approval

Investment Risks and Considerations

• Regulatory risk: Pending approval based on Phase 2 data presents uncertainty.
• Market risk: Slow adoption or off-label competition can limit revenue.
• Development risk: Adverse safety signals or lack of efficacy could delay or derail approval.
• Patent life: Patent applications filed in 2018, with patents potentially valid until 2038, provide market exclusivity.

Strategic Outlook

• Partnership potential: Large pharma firms seeking orphan drug assets may offer licensing or acquisition opportunities.
• Milestones impact: Pending Phase 3 results and regulatory submissions are primary catalysts.
• Market positioning: Nirogacestat has a clear niche, with prospects for accelerated approval due to rare disease designation.

Key Takeaways

Nirogacestat hydrobromide targets a niche in the gamma-secretase pathway with promising Phase 2 results and orphan drug designation. The drug addresses unmet needs in rare tumors like desmoid fibromatosis, with potential expansion into other indications. Financial expectations depend on clinical success, regulatory approval, and market penetration, with upside in licensing or partnership deals. Investor focus should monitor trial outcomes, regulatory decisions, and the competitive landscape.

FAQs

1. What are the primary clinical benefits of Nirogacestat?
It has demonstrated tumor shrinkage and symptom relief in desmoid tumors with a manageable safety profile in Phase 2.

2. What are the main risks for investment?
Potential failure in Phase 3 trials, regulatory delays, or competitors with better therapies pose risks.

3. When is regulatory approval expected?
Likely by late 2024 if Phase 3 data is positive and filings proceed without delays.

4. How does orphan drug designation impact the development process?
It can shorten review times, provide market exclusivity, and reduce development costs.

5. Which partners are involved or could be involved?
Current development is by Abbey V; potential partners include large pharma with capabilities in rare tumor markets.

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References

1. EvaluatePharma. (2022). Market size and revenue estimates for desmoid tumors.
2. GlobalData. (2022). Market analysis for gliomas.
3. U.S. Food and Drug Administration. (2018). Orphan Drug Designation criteria.
4. Pharmaceutical Research and Manufacturers of America (PhRMA). (2021). R&D cost analysis.