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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 twenty-six patents protecting this drug.

This drug has one hundred and four patent family members in forty-five 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.

Indicators of Generic Entry

Summary for OGSIVEO

International Patents:	104
US Patents:	26
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	2
Drug Prices:	Drug price information 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.

US Patents and Regulatory Information for OGSIVEO

OGSIVEO is protected by twenty-six 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	11,820,748		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,612,588		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,951,096
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	7,342,118			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	11,951,096
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,820,748		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	7,795,447			Y

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
Netherlands	1028598	Imidazoolverbindingen voor de behandeling van neurodegeneratieve ziekten.
Israel	311128	סינתזה של נירוגססטט (Synthesis of nirogacestat)
China	118043311	氯化四氢化萘化合物和药物组合物 (Tetrahydronaphthalene chloride compound and pharmaceutical composition)
China	114555562
Mexico	2022001743	FORMAS EN ESTADO SOLIDO DE (S)-2-(((S)-6,8-DIFLUOR-1,2,3,4-TETRAHI DRONAFTALEN-2-IL)AMINO)-N-(1-(2-METIL-1-(NEOPENTILAMINO)PROPAN-2- IL)-1H-IMIDAZOL-4-IL)PENTANAMIDA Y USOS DE LA MISMA. (SOLID STATE FORMS OF (S)-2-(((S)-6,8-DIFLUORO-1,2,3,4-TETRAHYDRON APHTHALEN-2-YL)AMINO)-N-(1-(2-METHYL-1-(NEOPENTYLAMINO)PROPAN-2- YL)-1H-IMIDAZOL-4-YL)PENTANAMIDE AND USES THEREOF.)
Japan	2022553479	（Ｓ）－２－（（（Ｓ）－６，８－ジフルオロ－１，２，３，４－テトラヒドロナフタレン－２－イル）アミノ）－Ｎ－（１－（２－メチル－１－（ネオペンチルアミノ）プロパン－２－イル）－１Ｈ－イミダゾール－４－イル）ペンタンアミドの固体状態形態およびその使用

OGSIVEO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OGSIVEO

Introduction

OGSIVEO (nirogacestat), developed by SpringWorks Therapeutics, has been a significant player in the treatment of adult patients with desmoid tumors since its U.S. launch. Here, we delve into the market dynamics and financial trajectory of OGSIVEO, highlighting key milestones, revenue growth, and future prospects.

Launch and Initial Revenue

The U.S. launch of OGSIVEO marked a critical milestone for SpringWorks Therapeutics. In the first quarter post-launch, OGSIVEO generated $5.4 million in net product revenue, setting the stage for its market penetration[5].

First Quarter 2024 Financial Results

In the first full quarter of the U.S. launch, OGSIVEO achieved $21.0 million in net product revenue. This strong execution was driven by robust commercial activities supporting the launch. The company's total operating expenses increased due to these commercial efforts, with SG&A expenses reaching $60.1 million for the first quarter of 2024[1][2].

Transition to Blister Packs

A significant factor contributing to the drug's growing adoption was the transition to blister packs. Introduced in early Q3 2024, these packs enhanced patient convenience and potentially improved compliance. By the end of the third quarter, approximately 65% of OGSIVEO patients were receiving the product in these blister packages[4].

Third Quarter 2024 Performance

The third quarter of 2024 saw continued strong commercial execution, with OGSIVEO net product revenue reaching $49.3 million, a 23% increase over the second quarter. This period also saw over 800 unique desmoid tumor patients filling an OGSIVEO script in September, and approximately 420 treatment centers ordering the drug since its approval[4].

Market Demand and Growth

Strong demand trends for OGSIVEO have been observed, particularly in the latter half of 2024. Analysts project consensus revenue expectations of $61.5 million for the fourth quarter, reflecting the growing adoption of the drug. The positive experiences of early adopters and increased physician familiarity are expected to drive further prescription rates[3].

Global Expansion

While current data focuses on the U.S. market, SpringWorks is working towards international launches. A Marketing Authorization Application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), which could open up new revenue streams and accelerate growth[1][4].

Reimbursement and Access

As real-world data accumulates, demonstrating OGSIVEO's value, SpringWorks may secure more favorable reimbursement terms from payers. This could increase both access and revenue, further solidifying the drug's market position[3].

Manufacturing Efficiencies

With increased production volumes, SpringWorks may achieve economies of scale, potentially improving profit margins over time. This efficiency could be crucial in maintaining a strong financial position as the company continues to invest in its pipeline[3].

Financial Position

SpringWorks Therapeutics maintains a strong financial position, with $573 million in cash, cash equivalents, and marketable securities as of the end of the first quarter of 2024. This financial runway supports ongoing R&D and commercialization efforts, despite the current high cash burn rate and reported losses[2][5].

SWOT Analysis

Strengths

• Strong demand trends for OGSIVEO
• Positive clinical data for other pipeline products like mirdametinib
• Successful transition to blister packs enhancing product accessibility
• Large addressable patient population[3]

Weaknesses

• Current unprofitability indicated by negative EPS estimates
• Reliance on a limited number of products in the pipeline
• Potential challenges in competing with established treatments[3]

Opportunities

• Expansion of OGSIVEO into additional indications or markets
• Potential for mirdametinib to outperform existing treatments
• Possibility of strategic partnerships or collaborations
• Growing market for rare disease treatments[3]

Threats

• Competitive pressure from established products
• Potential regulatory hurdles in drug approval processes
• Risk of clinical trial failures for pipeline products
• Market volatility affecting biotech sector investments[3]

Key Takeaways

• OGSIVEO has shown robust revenue growth since its U.S. launch, with significant increases in net product revenue each quarter.
• The transition to blister packs has enhanced patient convenience and compliance.
• Strong demand trends and a large addressable patient population bode well for long-term revenue growth.
• Global expansion and favorable reimbursement terms could further boost revenue.
• SpringWorks maintains a strong financial position to support ongoing R&D and commercial activities.

FAQs

Q: What was the net product revenue of OGSIVEO in the first quarter of 2024?

A: The net product revenue of OGSIVEO in the first quarter of 2024 was $21.0 million[1].

Q: How has the transition to blister packs impacted OGSIVEO adoption?

A: The transition to blister packs has enhanced patient convenience and potentially improved compliance, with approximately 65% of OGSIVEO patients receiving the product in these packs by the end of the third quarter 2024[4].

Q: What are the projected revenue expectations for OGSIVEO in the fourth quarter of 2024?

A: Analysts project consensus revenue expectations of $61.5 million for the fourth quarter of 2024, reflecting the growing adoption of the drug[3].

Q: What is the current status of OGSIVEO's Marketing Authorization Application (MAA) in Europe?

A: The MAA for nirogacestat is under review with the European Medicines Agency (EMA), which could open up new revenue streams and accelerate growth[1][4].

Q: How does SpringWorks Therapeutics' financial position support its ongoing activities?

A: SpringWorks maintains a strong financial position with $573 million in cash, cash equivalents, and marketable securities, providing a solid runway to support ongoing R&D and commercialization efforts[2].

Sources

1. SpringWorks Therapeutics Reports First Quarter 2024 Financial Results - SpringWorks Therapeutics.
2. SWTX Q1-2024 Earnings Call - Alpha Spread.
3. SpringWorks Therapeutics' SWOT analysis: stock shows promise amid challenges - Investing.com.
4. SpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights - GlobeNewswire.
5. SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates - Stock Titan.