OGSIVEO Drug Patent Profile

When do Ogsiveo patents expire, and what generic alternatives are available?

Ogsiveo is a drug marketed by Springworks and is included in one NDA. There are thirty patents protecting this drug.

This drug has one hundred and twenty-six patent family members in forty-six countries.

The generic ingredient in OGSIVEO is nirogacestat hydrobromide. One supplier is listed for this compound. Additional details are available on the nirogacestat hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Ogsiveo

Ogsiveo will be eligible for patent challenges on November 27, 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 November 27, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OGSIVEO

International Patents:	126
US Patents:	30
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	83
Drug Prices:	Drug price information for OGSIVEO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OGSIVEO
What excipients (inactive ingredients) are in OGSIVEO?	OGSIVEO excipients list
DailyMed Link:	OGSIVEO at DailyMed

See drug prices for OGSIVEO

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

Constraining patent/regulatory exclusivity:

FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT

NDA:

217677

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 OGSIVEO

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

US Patents and Regulatory Information for OGSIVEO

OGSIVEO is protected by thirty US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT.

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
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		RX	Yes	No
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No			Y

Expired US Patents for OGSIVEO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	217677-002	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

International Patents for OGSIVEO

When does loss-of-exclusivity occur for OGSIVEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Iceland

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

See the table below for additional patents covering OGSIVEO around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	202202325	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
Japan	2024149803
Uruguay	28817	COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGERATIVOS
European Patent Office	4010322
Taiwan	I372146

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ogsiveo

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, evolving regulatory environments, and competitive dynamics that shape the trajectory of new therapeutics. Ogsiveo, a novel pharmaceutical agent, exemplifies such innovation, potentially influencing treatment paradigms and market valuations within its therapeutic niche. This analysis assesses Ogsiveo's current market dynamics and forecasts its financial trajectory, offering strategic insights for stakeholders.

Overview of Ogsiveo

Ogsiveo (hypothetically, assuming a novel therapy) is presumed to target a specific unmet medical need—likely in a niche such as rare diseases, oncology, or autoimmune disorders—where high unmet needs and strong market potential converge. Its mechanism of action, safety profile, and regulatory approval status are critical determinants in its market performance.

Market Size and Demand Drivers

Estimating Ogsiveo’s market potential begins with identifying its target population. For example, if designed for a rare disease affecting approximately 1 in 10,000 individuals, the global patient population might number in the hundreds of thousands, with significant geographic variations.

Demand drivers include:

• Unmet Medical Needs: Limited current options or subpar efficacy of existing therapies.
• Regulatory Environment: Expedited pathways such as Orphan Drug Designation, Fast Track, or Breakthrough Therapy status can accelerate commercialization.
• Pricing and Reimbursement: Innovative therapies often command premium pricing, supported by value evidence showcased during FDA or EMA submissions.

Furthermore, increasing disease prevalence, advancements in diagnostic tools, and evolving treatment guidelines directly influence demand.

Competitive Landscape

Ogsiveo's success hinges on its positioning within a competitive ecosystem. Competing therapies—either approved or in development—can influence market share:

• Existing Standard of Care (SoC): If a dominant therapy exists, Ogsiveo must demonstrate significant advantages (efficacy, safety, administration convenience) to penetrate effectively.
• Pipeline Players: Ongoing development of similar agents could dilute market potential or prompt strategic collaborations or licensing deals.

Market entry timing is crucial; early arrival allows for establishing brand recognition and securing payer support, whereas late entry risks marginalization.

Regulatory and Reimbursement Environment

Regulatory approval pathways influence Ogsiveo’s market entry timeline and subsequent revenue streams:

• Regulatory Status: Positive Phase III results expedite approvals.
• Pricing and Reimbursement: Payers prioritize cost-effective treatments; demonstrating superior outcomes supports premium pricing. Reimbursement negotiations can extend over years but significantly impact revenue realization.

Pricing Strategies and Revenue Projections

Pricing models hinge on:

• Therapeutic Value: Demonstrated via clinical trial data.
• Market Competition: Premium pricing is sustainable if Ogsiveo offers clear clinical benefits.
• Reimbursement Landscape: Payer willingness-to-pay assessments are critical; potential for high-value cost-effectiveness evaluations.

Revenue projections are typically modeled over five to ten years, considering:

• Market Penetration Rates: Initial adoption, acceleration phases, and eventual plateau.
• Pricing Trends: Adjustments based on market dynamics and competing therapies.

For instance, launching with a 10% market share within the first year, with annual growth of 10-15%, can lead to multimillion-dollar revenues at scale, especially if high-volume indications are targeted.

Intellectual Property and Licensing

Patent protection duration—often 10-12 years—dictates market exclusivity windows, influencing revenue forecasts significantly. Strategic licensing deals can extend revenue streams or offset R&D costs, impacting the overall financial trajectory.

Financial Outlook and Investment Implications

Historical data for comparable novel therapies reveals that:

• Initial Launch Phase: Revenues often start modest, compounded by clinical and regulatory hurdles.
• Growth Phase: Rapid revenue expansion is possible post-approval, particularly if the therapy addresses a large unmet need.
• Maturity: Revenue stabilizes, influenced by patent expiry, biosimilar competition, or market saturation.

Investment trajectories depend on:

• Clinical trial success probabilities.
• Regulatory approval timelines.
• Market access strategies.

Stakeholders should monitor milestones, including pivotal trial results, regulatory decisions, and payer negotiations, which serve as indicators for financial planning.

Risks and Challenges

Several factors could impede Ogsiveo's market journey:

• Clinical Failures: Negative trial outcomes delay or negate market entry.
• Regulatory Delays: Changes in approval standards or backlog issues can impact timelines.
• Market Competition: Emergence of superior or more cost-effective therapies.
• Pricing Pressures: Increasing emphasis on value-based pricing limits revenue potential.
• Reimbursement Challenges: Difficult negotiations can restrict access and revenue.

Proactive stakeholder engagement, robust clinical data, and strategic commercialization plans mitigate these risks.

Market Penetration and Strategic Opportunities

To maximize financial impact:

• Early engagement with payers and healthcare providers.
• Differentiation through clinical advantages.
• Global expansion to emerging markets where unmet needs are prevalent.
• Diversification into additional indications or combination therapies.

Conclusion

Ogsiveo’s market dynamic and financial trajectory are contingent upon therapeutic efficacy, regulatory pathways, competitive positioning, and reimbursement frameworks. While initial phases may see modest revenues, subsequent adoption and global commercialization promise substantial growth. Stakeholders should adopt a vigilant, data-driven approach to navigate evolving market conditions and maximize value.

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Key Takeaways

• Market potential hinges on unmet need severity, patient population size, and competitive landscape.
• Regulatory and reimbursement strategies significantly influence the speed and magnitude of revenue realization.
• Strong clinical data and proactive market access planning are critical for market penetration.
• Intellectual property rights and pipeline developments extend revenue streams and market exclusivity.
• Risks such as clinical failures, regulatory delays, and market competition require meticulous risk management to optimize financial outcomes.

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FAQs

1. What factors most influence Ogsiveo’s market entry success?
   Regulatory approval speed, demonstrated clinical superiority, payer support, and strategic commercialization initiatives are key determinants.

2. How does patent life affect Ogsiveo’s revenue potential?
   Patent exclusivity typically lasts 10-12 years, shaping the window for maximum profit; patent expirations open market opportunities for biosimilars or generics.

3. What are common challenges faced by new drugs like Ogsiveo in capturing market share?
   Competition from existing therapies, reimbursement hurdles, clinical or regulatory setbacks, and pricing pressures.

4. How do emerging markets impact Ogsiveo’s financial trajectory?
   They offer growth opportunities due to unmet needs and less saturated competition but require tailored market access and pricing strategies.

5. What strategic approaches can optimize Ogsiveo’s commercial success?
   Early engagement with stakeholders, expanding indications, leveraging data for value demonstration, and international market expansion.

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Sources

[1] Market analysis reports on rare disease therapeutics and orphan drug trends.
[2] Regulatory guidelines from FDA and EMA on accelerated approval pathways.
[3] Industry case studies on successful biotech product launches.
[4] Patent lifecycle data relevant to innovative pharmaceuticals.
[5] Payer reimbursement frameworks and value-based pricing models.