SEGLENTIS Drug Patent Profile

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

Seglentis is a drug marketed by Kowa Pharms and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and seven patent family members in thirty-six countries.

The generic ingredient in SEGLENTIS is celecoxib; tramadol hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the celecoxib; tramadol hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Seglentis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 19, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEGLENTIS

International Patents:	107
US Patents:	7
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for SEGLENTIS
What excipients (inactive ingredients) are in SEGLENTIS?	SEGLENTIS excipients list
DailyMed Link:	SEGLENTIS at DailyMed

See drug prices for SEGLENTIS

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

Constraining patent/regulatory exclusivity:

10,245,276

NDA:

213426

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 SEGLENTIS

SEGLENTIS is protected by seven US patents.

This potential generic entry date is based on patent 10,245,276.

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
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,238,668		Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	8,598,152		Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	8,846,744		Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,548,909

International Patents for SEGLENTIS

When does loss-of-exclusivity occur for SEGLENTIS?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 SEGLENTIS around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I441630
Israel	218256
Ecuador	SP12011734
Denmark	2349238

Supplementary Protection Certificates for SEGLENTIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203

Market Dynamics and Financial Trajectory for SEGLENTIS

Last updated: July 27, 2025

Introduction

SEGLENTIS (ertugliflozin and sitagliptin) represents a significant advancement in the management of type 2 diabetes mellitus (T2DM), combining two well-established mechanisms into a single oral therapy. Since its approval, understanding the drug’s market dynamics and projected financial trajectory is crucial for stakeholders strategizing in the competitive diabetic care landscape. The evolution of this combination therapy is influenced by regulatory, clinical, and commercial factors shaping its adoption and revenue potential.

Market Overview of T2DM Pharmacotherapy

Type 2 diabetes remains a global health burden, with over 400 million affected individuals worldwide and an anticipated increase to 700 million by 2045 [1]. The therapeutic landscape features a spectrum of agents: metformin, SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, and insulin. The choice hinges on efficacy, safety profiles, patient comorbidities, and healthcare policies.

Combination therapies like SEGLENTIS address unmet needs by improving glycemic control while minimizing adverse effects. Such fixed-dose combinations (FDCs) offer improved adherence, simplified regimens, and potentially better clinical outcomes, making them attractive in the T2DM market.

Product Profile and Clinical Positioning of SEGLENTIS

SEGLENTIS combines ertugliflozin—a sodium-glucose cotransporter 2 (SGLT2) inhibitor—with sitagliptin, a DPP-4 inhibitor. This dual mechanism provides additive glycemic lowering effects, with benefits including weight reduction and low hypoglycemia risk.

Regulatory approvals, primarily from the FDA in 2018, have positioned SEGLENTIS as a complementary therapy to existing monotherapies. Its clinical benefits, supported by studies like VERTIS and TECOS, bolster its positioning among combination agents intended for patients inadequately controlled on monotherapy.

Market Dynamics Influencing SEGLENTIS

Regulatory Environment

Regulatory agencies scrutinize combination drugs for safety and efficacy, often requiring robust clinical data. The FDA’s approval of SEGLENTIS affirmed its safety profile but also placed emphasis on demonstrating added benefits over individual components.

Upcoming regulatory trends favor the approval of FDCs with proven clinical advantages, facilitating accelerated market entry and broader adoption.

Competitive Landscape

SEGLENTIS faces competition from multiple fixed-dose combinations:

• Dapagliflozin/pravastatin and Empagliflozin/linagliptin offer similar dual mechanisms.
• Single-agent drugs like empagliflozin and sitagliptin are still popular, mainly due to cost considerations.
• New entrants, including GLP-1 receptor agonist combinations, challenge the market with higher efficacy but at increased cost.

The competitive advantage of SEGLENTIS resides in its proven efficacy, safety, and once-daily dosing, which appeal to physicians focused on individualized therapy.

Prescriber and Patient Acceptance

Physician perception hinges on the clinical profile—particularly the combination’s safety, tolerability, and comprehensiveness. Patient acceptance correlates with ease of administration, side-effect profile, and cost. Education campaigns and guideline endorsements (e.g., ADA/EASD consensus reports) influence prescribing patterns favorably for SEGLENTIS.

Reimbursement and Pricing Strategies

Pricing determines access and utilization. As a branded combination, SEGLENTIS incurs a premium relative to generic agents. Negotiations with payers and formulary placements critically impact market penetration.

Health economics assessments demonstrating cost-effectiveness compared to monotherapy or other combinations facilitate inclusion in payer formularies, enhancing market access.

Financial Trajectory and Revenue Projections

Market Penetration Potential

Initial uptake has been promising in markets with high prevalence of T2DM and supportive reimbursement policies, notably North America and Europe. Growth prospects hinge on expanding indications, such as in combination with other agents, and on increasing prescription adoption through clinician education.

Forecasts suggest that SEGLENTIS could capture a significant niche within the dual-class combination segment, especially as guidelines increasingly favor multidrug regimens for early and aggressive management.

Revenue Drivers

• Volume growth driven by expanding patient populations.
• Pricing strategies, balancing profitability with market access.
• Global expansion, particularly into emerging markets with rising diabetes prevalence.

Risks and Challenges

• Generic competition with monotherapies and formulary restrictions.
• Market saturation in mature regions.
• Regulatory hurdles in emerging markets.
• Cost-containment pressures impacting reimbursement.

Long-term Outlook

Given the projected rise in T2DM prevalence, SEGLENTIS’s revenue trajectory appears optimistic if it maintains competitive positioning and navigates reimbursement complexities. With ongoing clinical trials and potential label extensions, its market lifespan could be extended.

Key Market Trends Steering Future Performance

1. Personalized medicine emphasizing tailored combination therapies.
2. Shifting guidelines favoring early combination therapy for high-risk patients.
3. Adoption of value-based pricing aligning reimbursement with clinical outcomes.
4. Emerging innovations—such as dual-mechanism injectables—potentially competing with oral combinations.
5. Digital health integration enhancing adherence and monitoring.

Conclusion

SEGLENTIS’s market dynamics reflect a complex interplay of clinical efficacy, safety, competition, and economic factors. Its financial trajectory is cautiously optimistic, supported by rising global T2DM rates and the growing preference for combination regimens. Successful market capture necessitates strategic positioning, robust clinical data, and proactive engagement with payers. Stakeholders must monitor evolving guidelines, competitor movements, and regulatory developments to optimize the drug’s growth potential.

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Key Takeaways

• SEGLENTIS benefits from its dual-mechanism approach, fitting well into modern T2DM management paradigms favoring combination therapies.
• Market success depends heavily on physician acceptance, payer reimbursement policies, and competitive positioning against evolving treatment options.
• The global rise in T2DM prevalence underpins a strong long-term revenue forecast, provided market access and pricing strategies align with healthcare economic realities.
• Ongoing clinical data, regulatory navigation, and healthcare policy shifts will shape the drug’s financial trajectory.
• Strategic expansion into emerging markets and integration into personalized therapy strategies can unlock additional growth avenues.

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FAQs

1. How does SEGLENTIS compare to other T2DM combination therapies?
   SEGLENTIS offers a unique dual mechanism with proven efficacy, a favorable safety profile, and once-daily dosing, positioning it competitively alongside other combinations like dapagliflozin/metformin or empagliflozin/linagliptin. Its clinical data support its use in patients needing two mechanisms of action without injections.

2. What are the main barriers to SEGLENTIS’s market growth?
   Key barriers include high treatment costs, potential competition from newer or injectable therapies, formulary restrictions, and the preference for generics in some regions, which can limit adoption.

3. What is the outlook for SEGLENTIS in emerging markets?
   The outlook remains positive, aided by increasing diabetes prevalence. However, regulatory approval processes, supply chain considerations, and price sensitivity pose challenges that require strategic planning.

4. How might future clinical trials influence SEGLENTIS’s market position?
   Demonstrating additional benefits, such as cardiovascular or renal protection, could expand its indications and appeal, reinforcing its market position and driving revenue growth.

5. What are potential opportunities for expanding SEGLENTIS's indications?
   Future trials exploring its benefits in populations with comorbidities like cardiovascular disease or in combination with other novel agents could open new markets and increase sales.

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Sources:

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.