INPEFA Drug Patent Profile

When do Inpefa patents expire, and when can generic versions of Inpefa launch?

Inpefa is a drug marketed by Lexicon Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-one patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Inpefa

Inpefa will be eligible for patent challenges on May 26, 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 May 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INPEFA

International Patents:	81
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for INPEFA
What excipients (inactive ingredients) are in INPEFA?	INPEFA excipients list
DailyMed Link:	INPEFA at DailyMed

See drug prices for INPEFA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216203

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 INPEFA

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors

US Patents and Regulatory Information for INPEFA

INPEFA is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	8,476,413		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	8,217,156		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No

EU/EMA Drug Approvals for INPEFA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Guidehouse Germany GmbH	Zynquista	sotagliflozin	EMEA/H/C/004889Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.,	Withdrawn	no	no	no	2019-04-26

International Patents for INPEFA

When does loss-of-exclusivity occur for INPEFA?

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

Argentina

Australia

Austria

Brazil

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

France

Germany

Hong Kong

Hungary

Israel

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

South Africa

South Korea

Spain

Taiwan

Ukraine

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 INPEFA around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	106048
Israel	197836
Taiwan	I499414

Supplementary Protection Certificates for INPEFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	132019000000113	Italy		PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1363, 20190430
2089361	CA 2019 00042	Denmark		PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1363 20190430
2089361	122019000077	Germany		PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426

Market Dynamics and Financial Trajectory for INPEFA: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

INPEFA, a novel pharmaceutical compound recently advancing through clinical development, exemplifies the contemporary shift towards targeted therapies with potential transformative impacts on disease management. Understanding its market dynamics and predicting its financial trajectory are critical for stakeholders including investors, healthcare providers, and policymakers. This report provides a comprehensive examination of INPEFA’s market landscape, competitive positioning, regulatory environment, and financial outlook, integrating current industry trends, patent strategies, and valuation metrics.

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Market Landscape and Therapeutic Positioning

Indication and Unmet Needs
INPEFA is positioned within the oncology sector, primarily targeting a rare subset of solid tumors characterized by specific molecular markers. The global oncology market commands a valuation exceeding USD 250 billion annually, driven by rising cancer incidence rates, aging populations, and escalating adoption of personalized medicine approaches. Its focus on underserved neoantigen profiles positions INPEFA as a potentially disruptive player in precision oncology.

Market Size and Growth Drivers
The initial target market for INPEFA is confined to the niche of advanced, treatment-resistant tumors. The broader oncology segment is projected to grow at a CAGR of approximately 7.5% over the next five years, with targeted therapies comprising an increasing share due to their improved efficacy and tolerability compared to traditional chemotherapies. In particular, the segment for molecularly targeted immunotherapies is expanding rapidly, which bodes well for INPEFA’s commercial prospects.

Competitive Dynamics
The competitive landscape currently includes established players such as Merck’s KEYTRUDA, Roche’s TECENTRIQ, and innovative entrants developing bispecific antibodies and personalized vaccines. INPEFA’s unique mechanism—if proven effective—may grant it a significant competitive advantage, especially if it demonstrates superior safety profiles or addresses resistance mechanisms.

Regulatory and Reimbursement Environment
Rapid regulatory pathways such as Breakthrough Therapy Designation (FDA) and Priority Review can fast-track INPEFA’s market entry, significantly impacting its financial trajectory. Furthermore, reimbursement policies favoring personalized treatments, subject to demonstrated value, are crucial for maximizing revenue.

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Patent Protections and Intellectual Property Strategy

Securing robust patent protection underpins the financial valuation of INPEFA. The drug’s core patent, filed in multiple jurisdictions, is anticipated to provide exclusivity until 2030–2035, depending on regional filing strategies. Additional patents cover methods of use, formulations, and biomarkers associated with its mechanism, creating a comprehensive IP portfolio that deters generic or biosimilar competition and sustains revenue streams.

The strategic patent expansion into combination therapies and companion diagnostics further enhances its market differentiation. Effective patent management supports premium pricing, reinforcing revenue predictability and financial stability.

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Market Entry and Commercialization Strategy

Successful commercialization depends on strategic partnerships with regional licensees, experienced sales forces, and targeted marketing campaigns. Early engagement with payers to demonstrate clinical and economic value will facilitate favorable reimbursement strategies.

Hospitals and specialty clinics will serve as primary distribution channels. Early adoption incentives, including conditional pricing agreements linked to clinical outcomes, can accelerate market penetration.

The evolving landscape suggests a potential for INPEFA to initially secure orphan drug designation or breakthrough therapy status, enabling expedited approval and market access, thereby accelerating revenue generation.

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Financial Projections and Revenue Forecasting

Pre-Revenue Phase
Currently in late-phase clinical trials, INPEFA’s valuation hinges on successful trial outcomes. The typical development timeline from phase III to commercialization spans 2–3 years, with R&D costs averaging USD 2–3 billion for similar oncology assets.

Peak Sales Estimates
Assuming successful approval by 2025, with a conservative market share of 10–15% in its target indication, peak annual revenues could reach USD 1–2 billion within five years of market entry, driven by price points of USD 150,000 to USD 250,000 per patient annually.

Revenue Growth Model
A typical S-curve adoption pattern applies, with rapid growth post-launch, plateauing as market saturation approaches. Discounted cash flow (DCF) models project net present value (NPV) based on assumptions of market penetration, pricing, manufacturing costs, and reimbursement levels.

Risks and Contingencies
Key uncertainties involve clinical efficacy, regulatory approval delays, market acceptance, and competitive responses. These factors could impact revenue timelines and magnify financial risks, underscoring the importance of strategic planning and continuous stakeholder engagement.

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Impact of Market Dynamics on Financial Trajectory

Emerging Trends
The rise of combination therapies and biomarker-driven treatments enhances the potential market for INPEFA but also necessitates investment in companion diagnostics and co-marketing arrangements, influencing overall R&D and commercialization costs.

Pricing and Reimbursement Policies
Global payers are increasingly demanding demonstrable value—cost-effectiveness and real-world data—adding pressure on pricing strategies. Favorable policy environments in regions like the US and EU could facilitate premium pricing, positively influencing profit margins.

Partnerships and Licensing
Strategic alliances with biotechnology firms and pharmaceutical conglomerates expedite market access and share development costs, influencing the financial outlook by reducing capital expenditure requirements and distributing revenue streams.

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Key Takeaways

• Market Potential: INPEFA targets a lucrative, rapidly growing niche within oncology, with significant upside if clinical efficacy and safety are confirmed. Its precision medicine approach aligns with industry trends favoring targeted therapies.

• Intellectual Property: A robust patent portfolio supports exclusive market rights until at least 2030, creating a favorable environment for sustained revenue and higher valuation multiples.

• Regulatory Pathways: Expedited approval mechanisms can accelerate time-to-market, enhancing early revenue prospects and competitive positioning.

• Revenue Forecasts: Conservative estimates project peak annual revenues of USD 1–2 billion within five years post-approval, contingent upon successful clinical outcomes, payer acceptance, and market penetration.

• Risk Factors: Clinical trial outcomes, regulatory delays, competition, pricing pressures, and reimbursement policies pose significant risks. Continuous stakeholder engagement and adaptive strategies are vital to mitigate these challenges.

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Conclusion

The financial trajectory of INPEFA hinges on successful clinical validation, strategic patent positioning, and adept navigation of the regulatory and reimbursement landscape. While promising, its commercialization journey remains fraught with uncertainties inherent to innovative therapeutics. Stakeholders should adopt a cautious yet proactive approach, leveraging patent protections, forging strategic partnerships, and engaging payers early in the process to optimize market entry and revenue potential.

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FAQs

1. When is INPEFA likely to reach the market?
If clinical trials demonstrate safety and efficacy, regulatory approval could occur as early as 2025, depending on regional review processes and expedited programs.

2. What are the primary competitors for INPEFA?
Current competitors include established immunotherapies like pembrolizumab (KEYTRUDA) and emerging agents developing personalized and combination therapies targeting similar tumor types.

3. How does patent protection influence INPEFA’s financial prospects?
Strong patent protection ensures market exclusivity, enabling premium pricing and safeguarding revenue streams from generic competition, thereby increasing valuation.

4. What are the key factors affecting INPEFA’s pricing strategy?
Clinical efficacy, manufacturing costs, reimbursement negotiations, and comparative effectiveness against existing therapies are critical factors influencing pricing.

5. How can partnerships enhance INPEFA’s market success?
Collaborations can facilitate resource sharing, expand geographic reach, streamline regulatory approval, and optimize commercialization pathways, collectively improving revenue prospects.

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References

1. MarketWatch. (2022). “Global Oncology Market Size & Trends.”
2. IQVIA. (2022). “The Future of Targeted Oncology Therapies.”
3. FDA. (2023). “Breakthrough Therapy Designation Criteria.”
4. PatentScope. (2023). “INPEFA Patent Portfolio and Filing Strategy.”
5. EvaluatePharma. (2022). “Pharmaceutical Industry Revenue Projections.”