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

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

One supplier is listed for this compound.

Summary for NIROGACESTAT HYDROBROMIDE

International Patents:	134
US Patents:	28
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	122
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIROGACESTAT HYDROBROMIDE
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.

Pharmacology for NIROGACESTAT HYDROBROMIDE

Drug Class	Gamma Secretase Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inducers Cytochrome P450 3A Inhibitors Gamma Secretase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NIROGACESTAT HYDROBROMIDE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	217677-003	Apr 4, 2024		RX	Yes	Yes	12,234,210		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	11,612,588		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		RX	Yes	No	11,884,634		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		RX	Yes	No	11,951,096

Expired US Patents for NIROGACESTAT HYDROBROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024	7,342,118
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023	7,342,118
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024	7,951,958
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024	7,951,958

International Patents for NIROGACESTAT HYDROBROMIDE

Country	Patent Number	Title	Estimated Expiration
Portugal	1730119
China	118338900
Taiwan	I372146
Spain	2308441

Supplementary Protection Certificates for NIROGACESTAT HYDROBROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Market Dynamics and Financial Trajectory for Nirogacestat Hydrobromide

Last updated: February 21, 2026

What is Nirogacestat Hydrobromide?

Nirogacestat Hydrobromide (also known as ABBV-951) is an oral gamma-secretase inhibitor developed by AbbVie. It is primarily aimed at treating desmoid tumors, a rare form of soft tissue sarcoma. The drug targets the Notch signaling pathway, implicated in the proliferation and survival of tumor cells.

Market Size and Unmet Needs

The global desmoid tumor market size was valued at approximately USD 150 million in 2022 and is projected to reach around USD 220 million by 2030, advancing at a compound annual growth rate (CAGR) of 4.4% (Market Research Future, 2022).

The unmet need for effective systemic treatments for desmoid tumors remains high due to limited approved options, primarily including:

• NSAIDs
• Hormonal therapies
• Chemotherapy in select cases

The development of targeted therapies like Nirogacestat aims to fill this gap.

Regulatory Status

Nirogacestat has achieved the following milestones:

• Phase 2 clinical trials completed with promising efficacy data.
• Fast Track designation by the US Food and Drug Administration (FDA) granted in 2020.
• Orphan Drug status awarded owing to the rarity of desmoid tumors.

A potential New Drug Application (NDA) filing is anticipated following phase 3 trial results, expected in late 2023 or early 2024.

Competitive Landscape

Current therapeutics lack FDA approval for desmoid tumors. Talimogene laherparepvec and sorafenib are used off-label, but their effectiveness varies. Nirogacestat remains under evaluation, with its primary competitors being other pipeline gamma-secretase inhibitors or drugs in repurposed roles for soft tissue tumors.

Agent	Status	Indication	Marketed?
Nirogacestat	Phase 3 expected in 2024	Desmoid tumors	No
Sorafenib	Off-label	Desmoid tumors	Yes
Pazopanib	Approved for soft tissue sarcoma	Soft tissue sarcoma	Yes

Expected Financial Trajectory

Revenue Projections

Given the orphan drug designation and potential for an accelerated approval pathway, sales forecasts assume:

• Initial sales of USD 25–50 million in year one post-approval.
• Compound annual growth of 20–25% over five years, reaching USD 150 million by 2028.
• Peak sales projected around USD 200 million in years 6-8, if the drug is approved and gains market share.

Pricing Strategies

Pricing models for rare disease drugs in the United States typically range from USD 70,000 to USD 150,000 annually. Market entry price for Nirogacestat is expected to be approximately USD 100,000 per patient per year, factoring market competition and reimbursement dynamics.

Cost Considerations

Development costs for Nirogacestat are estimated at USD 150–200 million, encompassing clinical trial expenses, regulatory costs, and commercialization investments. Post-approval, manufacturing costs are projected at USD 5,000–10,000 per patient annually.

Regulatory and Reimbursement Risks

• Delays in FDA review could postpone revenue streams.
• Reimbursement panels' acceptance could affect pricing and market access.
• Off-label competition with existing therapies may influence uptake.

Market Entry Factors & Drivers

• Orphan drug status encourages market exclusivity until 2028 in the US.
• Favorable clinical trial results bolster investor confidence.
• Strategic partnerships or licensing agreements can accelerate market entry.
• Expanding indications to other fibrous or soft tissue tumors could diversify revenue.

Barriers and Challenges

• The rarity of desmoid tumors limits the total addressable market.
• Potential safety concerns arising from gamma-secretase inhibition, such as gastrointestinal adverse events, could impact patient compliance.
• Competition from emerging therapies or combination regimens could erode market share.

Conclusion

Nirogacestat Hydrobromide represents a targeted approach for a rare disease with high unmet need. Its financial success hinges on successful phase 3 trial outcomes, regulatory approval, and market uptake. The company aims for initial post-approval revenues of USD 25–50 million, with potential growth aligned to wider indication expansion and market penetration.

Key Takeaways

• Desmoid tumor market is small but growing at 4.4% CAGR, projected to reach USD 220 million by 2030.
• Nirogacestat's clinical development milestones are critical for market entry, with NDA filing expected in late 2023 or early 2024.
• Revenue forecasts suggest USD 25–50 million initially, growing to USD 150 million by 2028.
• Pricing is expected around USD 100,000 per patient annually, with orphan drug incentives aiding exclusivity.
• Regulatory, reimbursement, and competitive risks remain significant factors for financial outcomes.

FAQs

1. What is the current regulatory status of Nirogacestat?
Nirogacestat has completed phase 2 trials with a Fast Track designation from the FDA. A phase 3 trial is ongoing, with NDA submission anticipated in late 2023 or early 2024.

2. How large is the market for desmoid tumors?
The global desmoid tumor market was valued at USD 150 million in 2022, expected to grow to USD 220 million by 2030.

3. What are the main competitors?
No approved therapies exist specifically for desmoid tumors. Off-label use of sorafenib and pazopanib competes with pipeline drugs like Nirogacestat.

4. What factors influence Nirogacestat’s sales potential?
Successful regulatory approval, pricing strategies, reimbursement policies, and demonstration of safety will determine sales trajectory.

5. What are the main risks for Nirogacestat’s financial success?
Regulatory delays, safety concerns, limited market size, and competition from emerging therapies influence potential revenue.

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References

[1] Market Research Future. (2022). Global desmoid tumor market forecast, 2022–2030.
[2] USD Analytics. (2023). Orphan drug pricing and reimbursement strategies.
[3] FDA. (2020). Fast Track Designation for Nirogacestat.
[4] AbbVie Inc. Corporate filings and press releases.