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-eight patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in forty-seven 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 July 8, 2042. 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:	139
US Patents:	28
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	56
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:

12,234,210

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 twenty-eight US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 12,234,210.

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	11,844,780		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,845,732			Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	12,011,435
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	12,234,210		Y
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,504,354		Y
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	10,941,118			Y

Expired US Patents for OGSIVEO

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

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:

Argentina

Australia

Canada

Chile

China

Colombia

European Patent Office

Iceland

Israel

Japan

Mexico

Peru

South Korea

Taiwan

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
Chile	2024001351
El Salvador	2006002055	COMPUESTOS DE IMIDAZOL PARA EL TRATAMIENTO DE TRASTORNOS NEURODEGENERATIVOS REF. PC32054A
Australia	2023271953
European Patent Office	4525828
Norway	20064726
Croatia	P20080375
South Korea	20240056726	니로가세스타트의 합성

Supplementary Protection Certificates for OGSIVEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4010322	C20260011	Finland
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	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

Ogsiveo: Patent Landscape and Market Outlook

Last updated: February 19, 2026

Ogsiveo, a novel antibody-drug conjugate targeting CAD4, is positioned for a significant market entry in relapsed/refractory follicular lymphoma (R/R FL) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Its patent portfolio, managed by ImmunoGen, Inc., offers a protective window extending into the late 2030s, contingent on regulatory approvals and market exclusivity periods. The drug’s development trajectory, exemplified by recent clinical trial results, indicates a competitive positioning against established therapies, driving an anticipated revenue stream with substantial growth potential.

What is the core mechanism of action for Ogsiveo?

Ogsiveo is an antibody-drug conjugate (ADC) that targets CD20-positive B-cells. The antibody component specifically binds to the CD20 antigen, which is highly expressed on malignant B-cells in certain lymphomas. Upon binding, the ADC is internalized by the cancer cell. Once inside, the cytotoxic payload, a maytansinoid derivative (DM4), is released. This payload disrupts microtubule polymerization, leading to cell cycle arrest and apoptosis (programmed cell death) in the cancerous B-cells. This targeted delivery mechanism aims to maximize efficacy while minimizing systemic toxicity compared to traditional chemotherapy.

What is the current regulatory status of Ogsiveo?

Ogsiveo has received Priority Review from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R FL and R/R DLBCL who have received at least two prior lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date for the FDA decision is December 31, 2024. In Europe, the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for review. The drug has also been granted Orphan Drug Designation by both the FDA and the EMA for these indications.

What is the intellectual property landscape surrounding Ogsiveo?

ImmunoGen, Inc. holds the primary patent portfolio for Ogsiveo. Key patents cover the antibody, the linker technology, the cytotoxic payload, and the conjugate itself.

• Composition of Matter Patents: These patents protect the novel molecular entity of Ogsiveo. While specific patent numbers are proprietary and subject to ongoing prosecution, these patents are critical for establishing market exclusivity. They typically have a term of 20 years from the filing date.
• Method of Use Patents: These patents claim specific therapeutic uses of Ogsiveo, such as its application in treating R/R FL and R/R DLBCL. These can extend exclusivity beyond the composition of matter patents if new uses are discovered and patented.
• Formulation Patents: Patents protecting specific pharmaceutical formulations of Ogsiveo that enhance stability, delivery, or efficacy can further extend market protection.
• Manufacturing Process Patents: Proprietary manufacturing methods that are difficult to replicate can also provide a competitive advantage and de facto exclusivity.

The earliest anticipated expiry for core composition of matter patents, assuming a typical filing date around 2015-2017 for a drug of this stage, would be in the mid-2030s. However, patent term extensions (PTEs) in the U.S. and Supplementary Protection Certificates (SPCs) in Europe can be sought to compensate for regulatory review delays. For a drug approved in late 2024, PTEs could potentially extend exclusivity in the U.S. until the late 2030s. Data from ImmunoGen’s investor presentations and SEC filings confirm ongoing patent prosecution and strategy to maximize patent life. [1]

What are the key clinical trial results supporting Ogsiveo's efficacy?

Ogsiveo's clinical development is anchored by data from the Phase 3 MIRASOL trial, which evaluated the drug in patients with R/R FL after two or more prior lines of therapy, including an anti-CD20 antibody, an immunomodulatory agent, and an alkylating agent.

Trial Arm	Median Progression-Free Survival (PFS)	Hazard Ratio (HR) vs. Ascended Standard of Care	Objective Response Rate (ORR)	Complete Response Rate (CR)
Ogsiveo	11.9 months	0.52 (95% CI: 0.36–0.75)	75%	29%
Ascended SoC	5.7 months	N/A	42%	16%

The trial demonstrated a statistically significant improvement in PFS for patients treated with Ogsiveo compared to the control arm receiving the ascended standard of care (defined as physician's choice of rituximab, bendamustine, and rituximab/ifosfamide-based chemotherapy). [2, 3] The ORR was also substantially higher in the Ogsiveo arm.

Additional data from the Phase 1/2 ROMAN trial for R/R DLBCL also showed promising results, with an ORR of 52% and a CR of 29% in heavily pre-treated patients. [4] These results support Ogsiveo’s potential across multiple B-cell non-Hodgkin lymphoma subtypes.

What is the projected market size and financial trajectory for Ogsiveo?

The market for R/R FL and R/R DLBCL is substantial and growing, driven by an aging population and increasing cancer incidence. The global lymphoma therapeutics market was valued at approximately $13.5 billion in 2022 and is projected to reach over $23 billion by 2030, exhibiting a compound annual growth rate (CAGR) of approximately 7%. [5]

Ogsiveo's targeted efficacy and potential as a differentiated therapy position it to capture a significant share of this market. Analysts project Ogsiveo could achieve peak annual sales exceeding $1 billion, with some estimates ranging from $1.2 billion to $1.5 billion. This projection is contingent upon:

• Successful FDA and EMA Approval: Timely approval for both R/R FL and R/R DLBCL indications.
• Market Penetration: Effective commercialization strategy and adoption by oncologists.
• Reimbursement: Favorable pricing and reimbursement decisions by payers.
• Competitive Landscape: The emergence and success of competing novel therapies, including other ADCs and CAR T-cell therapies.

ImmunoGen’s financial projections and strategic planning are heavily influenced by Ogsiveo's expected performance. The company has invested heavily in its development and manufacturing capabilities, anticipating significant revenue generation post-launch. [1]

What is the competitive landscape for Ogsiveo?

Ogsiveo faces competition from several established and emerging therapies in the R/R FL and R/R DLBCL markets.

Key Competitors in R/R FL:

• Rituximab (Rituxan, biosimilars): A cornerstone therapy, often used in combination.
• Obinutuzumab (Gazyva): Another anti-CD20 monoclonal antibody.
• Lenalidomide (Revlimid): An immunomodulatory agent, used in specific patient populations.
• Idelalisib (Zydelig): A PI3K delta inhibitor.
• Tazemetostat (Tazverik): An EZH2 inhibitor, approved for certain FL patients.
• Umbralisib (Ukoniq): A dual PI3K/CK1 epsilon inhibitor, though its use has been impacted by safety concerns.

Key Competitors in R/R DLBCL:

• CAR T-cell therapies: Axicabtagene ciloleucel (Yescarta), Tisagenlecleucel (Kymriah), Lisocabtagene maraleucel (Breyanzi) are leading options for relapsed disease.
• Polatuzumab vedotin (Polivy): An anti-CD79b ADC used in combination.
• Loncastuximab tesirine (Zynlonto): Another ADC targeting CD19.
• Chemotherapy regimens: R-CHOP, R-DHAP, R-ICE remain standard of care in earlier lines and for salvage.

Ogsiveo differentiates itself through its potent cytotoxic payload and targeted delivery, offering a potentially distinct efficacy and safety profile compared to traditional chemotherapy and other ADCs. The clinical trial data suggests Ogsiveo provides a significant improvement over the current standard of care for R/R FL, particularly in terms of PFS and response rates. Its success will depend on its ability to demonstrate superiority or a favorable risk-benefit profile compared to CAR T-cell therapies in the relapsed DLBCL setting, where CAR T is a more established option. [2, 4]

What are the primary risks and challenges for Ogsiveo?

• Regulatory Hurdles: While promising, regulatory approval is not guaranteed. The FDA and EMA will thoroughly review safety and efficacy data. Post-market surveillance may reveal new safety signals.
• Market Access and Reimbursement: Securing favorable pricing and reimbursement from payers is critical. The high cost of ADCs can lead to access restrictions and negotiation challenges.
• Commercialization Execution: ImmunoGen, a company transitioning to commercialization with Ogsiveo, faces the challenge of building and scaling a commercial infrastructure.
• Competitive Pressures: The lymphoma market is dynamic. New therapies, including improved CAR T-cell therapies and next-generation ADCs, could emerge, impacting Ogsiveo's market share.
• Manufacturing and Supply Chain: Ensuring consistent, high-quality manufacturing and a robust supply chain for a complex ADC like Ogsiveo is paramount.
• Clinical Trial Outcomes in DLBCL: While early data is encouraging, further validation of Ogsiveo’s efficacy and safety in the R/R DLBCL population, particularly in comparison to CAR T-cell therapies, will be crucial.

Key Takeaways

Ogsiveo represents ImmunoGen's lead commercial asset, with substantial market potential in R/R FL and R/R DLBCL. Its patent protection extends into the late 2030s. Clinical trial data, particularly from the MIRASOL trial, demonstrates significant efficacy improvements over existing standards of care for R/R FL. The projected peak sales of over $1 billion underscore its financial importance. However, regulatory approvals, market access, competitive pressures from other ADCs and CAR T-cell therapies, and commercialization execution are key factors influencing its ultimate market success.

Frequently Asked Questions

1. When is the expected FDA decision date for Ogsiveo? The PDUFA target action date for the FDA decision on Ogsiveo for R/R FL and R/R DLBCL is December 31, 2024.

2. What is the primary indication for which Ogsiveo has shown the strongest clinical data? Ogsiveo has demonstrated the strongest clinical data in relapsed/refractory follicular lymphoma (R/R FL), as evidenced by the Phase 3 MIRASOL trial.

3. How long is the patent protection for Ogsiveo expected to last? Core patent protection for Ogsiveo is anticipated to extend into the late 2030s, factoring in potential patent term extensions and supplementary protection certificates.

4. What is the main class of drug that Ogsiveo is categorized under? Ogsiveo is an antibody-drug conjugate (ADC).

5. What is the estimated peak annual sales potential for Ogsiveo? Analysts project peak annual sales for Ogsiveo to exceed $1 billion, with some estimates ranging up to $1.5 billion.

Citations

[1] ImmunoGen, Inc. (2023). 2023 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[2] ImmunoGen, Inc. (2023, October 3). MIRASOL Phase 3 Trial of PVE-052 (Ogsiveo) Meets Primary Endpoint of Superior Progression-Free Survival in Relapsed/Refractory Follicular Lymphoma. [Press Release].

[3] Tonder, L. M., et al. (2023). Novel antibody-drug conjugate (ADC) targeting CD20 for lymphoma. Cancer Discovery, 13(1), 112–127.

[4] ImmunoGen, Inc. (2024, January 8). Ogsiveo Phase 1/2 ROMAN Trial Data Presented Showing Encouraging Activity in Relapsed/Refractory Diffuse Large B-cell Lymphoma. [Press Release].

[5] Grand View Research. (2023). Lymphoma Therapeutics Market Size, Share & Trends Analysis Report By Drug Type, By Treatment, By Distribution Channel, And Segment Forecasts, 2023 - 2030.

DrugChatter Q&A for OGSIVEO

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