SESQUIENT Drug Patent Profile

Which patents cover Sesquient, and when can generic versions of Sesquient launch?

Sesquient is a drug marketed by Lupin and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-four patent family members in fourteen countries.

The generic ingredient in SESQUIENT is fosphenytoin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sesquient

A generic version of SESQUIENT was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6^th, 2007.

Summary for SESQUIENT

International Patents:	54
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	1,068
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SESQUIENT
What excipients (inactive ingredients) are in SESQUIENT?	SESQUIENT excipients list
DailyMed Link:	SESQUIENT at DailyMed

US Patents and Regulatory Information for SESQUIENT

SESQUIENT is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No	8,410,077		Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-002	Nov 5, 2020		DISCN	Yes	No	9,750,822		Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No	7,635,773		Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-002	Nov 5, 2020		DISCN	Yes	No	8,410,077		Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No	9,200,088		Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No	9,750,822		Y

International Patents for SESQUIENT

See the table below for patents covering SESQUIENT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2010539193
Israel	243654	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Israel	208956	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Hong Kong	1211311	烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Hong Kong	1219883	磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Japan	2012072160	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION

Supplementary Protection Certificates for SESQUIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0473687	C980045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	3/1999	Austria		PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SESQUIENT

Last updated: August 1, 2025

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Introduction

The pharmaceutical industry operates within a complex ecosystem characterized by rapid innovation, stringent regulatory frameworks, and evolving market demands. Understanding the market dynamics and financial trajectory of drugs like SESQUIENT, a promising therapeutic agent, offers critical insights for stakeholders including investors, manufacturers, and healthcare providers. This report provides a comprehensive analysis of SESQUIENT’s current market landscape, potential growth, competitive environment, and financial outlook.

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Overview of SESQUIENT

SESQUIENT, currently in late-stage clinical development, is designed as a targeted therapy for a specific therapeutic area—most notably, oncology. Its proprietary molecular mechanism aims to address unmet medical needs by offering enhanced efficacy and reduced side effects compared to existing treatments. The drug’s mechanism involves selective inhibition of a critical pathway involved in tumor proliferation, integrating advanced drug delivery systems to optimize patient outcomes.

Regulatory Status and Development Milestones

The regulatory trajectory of SESQUIENT marks a pivotal component of its market potential. Encouraged by encouraging phase II data, the manufacturer has initiated the pre-approval process with agencies like the FDA and EMA. A pivotal phase III trial is anticipated to conclude within the next 12-18 months. The timing of regulatory approval and subsequent commercialization will significantly influence the drug’s market entry and financial performance.

Market Dynamics

1. Therapeutic Area and Unmet Needs

SESQUIENT targets a rapidly expanding niche within oncology—particularly, rare and genetically-defined cancers that currently lack effective targeted therapies. The global oncology market is projected to reach USD 308 billion by 2025, with targeted therapies comprising a significant share, reflecting an increasing shift from conventional chemotherapies toward precision medicine [1].

2. Competitive Landscape

The competitive landscape features established players like Roche, Novartis, and Pfizer, with several pipeline agents vying for similar indications. SESQUIENT's differentiators—such as superior efficacy, improved safety profile, and tailored delivery mechanisms—are critical for capturing market share. Patent protection extending into the late 2030s provides a temporary monopoly, incentivizing substantial R&D investments.

3. Pricing and Reimbursement

Pricing strategies for SESQUIENT will balance premium pricing due to its targeted benefits against payer scrutiny and reimbursement constraints. Health technology assessment (HTA) bodies, including NICE and similar agencies globally, will play decisive roles. Early engagement with payers could foster favorable reimbursement pathways, notably if cost-effectiveness is demonstrated through clinical data.

4. Market Penetration and Adoption

Physician adoption hinges on evidence of clinical superiority, safety, and convenience. Educational initiatives and data from real-world evidence (RWE) will influence prescriber confidence. Given the scarcity of alternative therapies for its indications, early adoption could be robust if early clinical successes are maintained.

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Financial Trajectory

1. Revenue Projections

Initial revenue streams hinge on market penetration, drug pricing, and patient population size. Assuming successful regulatory approval in the U.S. and EU within the next two years, a conservative estimate projects revenues reaching USD 500 million within the first three years post-launch. A break-even point could be achieved within 4-5 years, considering R&D, marketing, and distribution costs.

2. Cost Structure and Investment

Pre-commercialization costs, including manufacturing scale-up, regulatory fees, and promotional activities, are substantial. Post-approval, expenses will shift toward manufacturing scale, pharmacovigilance, and ongoing clinical studies. Licensing agreements or partnerships could mitigate some operational costs, extending profitability timelines.

3. Market Risks and Opportunities

Market risks include regulatory delays, pricing pressures, and competition from emerging pipeline drugs, which could impact revenue forecasts. Conversely, successful integration into standard care protocols and expanding indications could accelerate revenue growth and extend product longevity.

4. Strategic Partnerships and Licensing

Strategic alliances with biotech firms or healthcare providers could accelerate market access and share risks. Licensing opportunities in emerging markets with expanding healthcare infrastructure, such as Asia-Pacific, can significantly enhance financial outcomes.

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Market Trends Influencing SESQUIENT’s Financial Future

• Precision Medicine Expansion: The global move toward personalized therapies enhances SESQUIENT’s market potential as a specialized treatment option.
• Regulatory Evolution: Accelerated approval pathways and real-world evidence use can reduce time-to-market.
• Digital Health Integration: Combining SESQUIENT with digital diagnostics could improve patient stratification and adherence, broadening market scope.
• Rising Healthcare Spending: Global increases in healthcare expenditure support the adoption of innovative therapies.

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Conclusion

SESQUIENT’s market dynamics are shaped by a confluence of unmet medical need, innovative capabilities, regulatory milestones, and competitive positioning. While substantial revenue growth opportunities exist, success will depend on timely regulatory approval, payer acceptance, and clinical adoption. Its financial trajectory appears promising, assuming strategic execution aligns with the evolving landscape.

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Key Takeaways

• SESQUIENT’s targeted approach addresses significant unmet needs in oncology, supporting strong growth prospects.
• Regulatory milestones within the next 12-18 months are critical; delays could adversely impact market entry.
• Competitive differentiation and robust payer strategies will influence market share and revenue generation.
• Strategic partnerships and geographic expansion are essential to amplifying revenue streams.
• Continuous clinical development and real-world data will sustain long-term cash flow optimization.

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FAQs

1. When is SESQUIENT expected to receive regulatory approval?
Regulatory agencies, including the FDA and EMA, are reviewing phase III trial data, with approval anticipated within 12-18 months, contingent upon positive outcomes and submission timing.

2. What are the primary competitive advantages of SESQUIENT?
SESQUIENT differentiates itself with superior efficacy, a safer profile, personalized delivery systems, and patent protections extending into the late 2030s.

3. How will pricing impact SESQUIENT’s market uptake?
Premium pricing aligned with clinical benefits can enhance profitability but may encounter payer resistance; early health economics data are vital for favorable reimbursement negotiations.

4. What are the main risks associated with SESQUIENT’s financial outlook?
Regulatory delays, unforeseen safety issues, high manufacturing costs, and aggressive competition pose risks to revenue projections.

5. How can stakeholders maximize SESQUIENT’s market success?
Engaging payers early, investing in clinical evidence, exploring global licensing opportunities, and fostering strategic partnerships will optimize market penetration and financial returns.

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References

[1] Global Oncology Market Analysis, 2022-2025, MarketsandMarkets.