SEGLUROMET Drug Patent Profile

Which patents cover Segluromet, and what generic alternatives are available?

Segluromet is a drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-seven patent family members in forty-nine countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Segluromet

Segluromet was eligible for patent challenges on December 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been three 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 SEGLUROMET

International Patents:	87
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for SEGLUROMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEGLUROMET
What excipients (inactive ingredients) are in SEGLUROMET?	SEGLUROMET excipients list
DailyMed Link:	SEGLUROMET at DailyMed

See drug prices for SEGLUROMET

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

NDA:

209806

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.

Recent Clinical Trials for SEGLUROMET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all SEGLUROMET clinical trials

Pharmacology for SEGLUROMET

Drug Class

Biguanide

US Patents and Regulatory Information for SEGLUROMET

SEGLUROMET is protected by three US patents.

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
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-004	Dec 19, 2017		RX	Yes	Yes			Y	Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No			Y

EU/EMA Drug Approvals for SEGLUROMET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Segluromet	ertugliflozin, metformin hydrochloride	EMEA/H/C/004314Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.	Authorised	no	no	no	2018-03-23

International Patents for SEGLUROMET

When does loss-of-exclusivity occur for SEGLUROMET?

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

African Regional IP Organization (ARIPO)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

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 SEGLUROMET around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2728
Argentina	073138
Austria	E540040
Australia	2009286380

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	122018000070	Germany		PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	300943	Netherlands		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687	LUC00079	Luxembourg		PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323

Segluromet Market Dynamics and Financial Trajectory (Systemic Glucose-Lowering Combination of Ertugliflozin + Metformin)

Last updated: June 28, 2026

Segluromet (ertugliflozin + metformin) is a marketed SGLT2 inhibitor plus metformin fixed-dose combination positioned in type 2 diabetes. Public, decision-grade revenue and volume visibility for Segluromet is limited because company reporting is largely product-line aggregated and not consistently separated by individual fixed-dose combinations across major geographies. Market dynamics are shaped by (1) SGLT2 class share shifts driven by outcomes data and payer adoption, (2) formulary movement between branded SGLT2 products, (3) generic and LOE pressure on metformin, and (4) lifecycle risk tied to subsequent fixed-dose entrants and plan design.

H1: Segluromet (Ertugliflozin + Metformin) market share, revenue trend, pricing pressure, and competitive dynamics

What is Segluromet’s market position in type 2 diabetes versus other SGLT2 inhibitor combinations?

Segluromet competes in a high-growth, high-formulary-scrutiny segment: SGLT2 inhibitors combined with metformin (fixed-dose or co-administered). The practical competitive set includes branded SGLT2 plus metformin combinations and branded SGLT2 monotherapies that payers prefer when they can use preferred tiers and reduce cost-sharing.

How does Segluromet compare with key SGLT2 plus metformin fixed-dose competitors?

The competitive landscape typically falls into two buckets:

• Fixed-dose SGLT2 + metformin combinations
  • Examples in the US commercial market include products branded around dapagliflozin/metformin, empagliflozin/metformin, and other SGLT2-metformin combinations depending on availability and approvals.
• SGLT2 monotherapy with separate metformin
  • Often wins on formulary flexibility: plans can cover SGLT2 as a preferred class drug while metformin is generics, driving lower total copays.

Segluromet’s market dynamics tend to reflect:

• Class share competition among branded SGLT2s, not just across fixed-dose combinations.
• Payer preference for reduced pill burden when rebates and net price are favorable.
• Switching friction from background regimens, since fixed-dose requires a conversion from existing dosing.

What are the main drivers of Segluromet demand, adoption, and payer penetration?

Segluromet’s utilization is driven by a combination of clinical positioning and reimbursement levers.

Payer and formulary drivers that influence prescribing

• SGLT2 formulary placement
  • In many commercial plans, SGLT2 inhibitors are placed on preferred tiers with prior authorization criteria that can include A1c thresholds, intolerance to metformin-only regimens, and documentation of T2D diagnosis.
• Net pricing and rebate structure
  • Branded SGLT2 outcomes and access performance often track rebate competitiveness and contract coverage rather than list price alone.
• Fixed-dose logistics
  • Fixed-dose can improve adherence and reduce pill burden, but adoption depends on whether the plan covers the exact strengths needed for titration.

Clinical and endpoint-based drivers

• Cardiovascular and renal outcome positioning
  • The SGLT2 class benefits from outcomes data that have been incorporated into guideline pathways, influencing payer willingness to cover after basic therapy failure.
• Tolerability and comorbidity fit
  • SGLT2 uptake is sensitive to patient selection, including baseline renal function and risk management for genital infections, dehydration risk, and ketoacidosis warnings.

When does Segluromet face exclusivity and generic entry risk under US patent and Hatch-Waxman frameworks?

Segluromet is an FDA-regulated small-molecule combination. Generic entry risk is governed by:

• Composition and method patents
• Orange Book-listed patents
• Hatch-Waxman paragraph IV challenges
• Any pediatric exclusivity and regulatory exclusivity dates tied to approved labeling

However, a complete, decision-grade exclusivity and entry timeline for Segluromet requires product-specific Orange Book listing data and the associated patent estate. Without that listing-level dataset in the provided context, a definitive expiration and generic launch window cannot be stated.

What is the Orange Book status of Segluromet and which patents control its US competition risk?

Orange Book status is the primary control mechanism for US generic and biosimilar competition. A complete control map for Segluromet requires:

• Orange Book drug product identification
• Listed active ingredient patents and associated expiration dates
• Method-of-use patents tied to labeling
• Any currently listed exclusivity periods

Those Orange Book details are not provided in the available input context, so a complete patent-control table for Segluromet cannot be constructed here.

How do Segment economics for Segluromet work: price, volume, and mix effects?

Branded SGLT2 combination economics typically break down into:

• Net price vs list price
  • Rebates and payer contracts can drive net pricing significantly below list.
• Volume and mix
  • Mix shifts between doses (and between fixed-dose and co-administered regimens) determine revenue sensitivity.
• Patient persistence
  • Adherence and switching affect how much of the initially treated population stays on the brand rather than switching to a lower-cost alternative.

Given limited product-level financial disclosure, the most reliable method to forecast Segluromet revenue is to model:

• SGLT2 class total prescriptions in the US
• Share allocation to ertugliflozin-based brands
• Share of “metformin combination” initiation vs monotherapy patterns
• Discontinuation and switching toward preferred SGLT2 brands

That model requires baseline prescription share data and product-level sales reporting that are not included here.

Which company financial statements show Segluromet’s revenue trajectory, and what are the observable trends?

Segluromet’s commercial performance is tied to the issuer that markets ertugliflozin-containing products in the relevant territory. A robust financial trajectory requires:

• Extracting product-specific or segment-level revenue attribution from filings (10-K/10-Q)
• Mapping calendar-time sales changes to contract events (rebates, formularies), label updates, and competitor launches

The input context does not provide Segluromet sales figures, company reporting extracts, or filing references. As a result, an evidence-backed numeric trajectory cannot be produced.

What commercial events have the biggest impact on Segluromet growth or decline?

For SGLT2 plus metformin brands, the largest swings usually come from:

• Formulary contract wins/losses
• Competitive launches in fixed-dose combinations
• Payer restrictive utilization management tightening
• Wholesale inventory corrections
• Safety signal-driven discontinuations
• Guideline shifts that change initiation criteria

A Segluromet-specific event timeline with dates and observable impacts requires evidence not included in the provided context.

How does Segluromet’s competitive landscape affect its medium-term financial outlook?

Market share dynamics inside the SGLT2 class

SGLT2 brands compete intensely on:

• outcomes evidence,
• payer contracting and rebates,
• patient acquisition efficiency,
• and fixed-dose convenience.

In medium-term horizons (12 to 36 months), the major determinants for Segluromet are:

• Whether it stays on “preferred” tiers relative to other SGLT2 options.
• Whether its fixed-dose strengths match standard titration pathways.
• Whether it wins conversions from other SGLT2-to-SGLT2 switches.

Switching risk from other fixed-dose combinations

Fixed-dose combinations can displace each other when:

• plans prefer one product line’s pricing,
• adherence programs are aligned to a specific brand,
• and dosing convenience matches patient needs.

What generic entry risks exist for Segluromet, and what would they do to pricing and sales?

Generic entry pressure in this category typically triggers:

• immediate tier compression (from preferred brand coverage to narrower coverage),
• copay assistance withdrawal or reduction,
• rebate re-optimization,
• and rapid share shift to generics if the active ingredient is available.

A specific generic entry risk assessment for Segluromet requires Orange Book-controlled expiration timelines and any pending paragraph IV litigation status, which are not included in the provided context.

Key takeaways

• Segluromet competes in the SGLT2 inhibitor plus metformin fixed-dose niche within a broader SGLT2 class marketplace where payer contracting and preferred-tier status drive the majority of net revenue outcomes.
• Demand is primarily shaped by formulary access, rebate competitiveness, patient persistence, and fixed-dose adoption friction.
• A numeric financial trajectory, exclusivity timeline, and generic-competition forecast for Segluromet cannot be stated from the provided input because Segluromet-specific sales figures and Orange Book/patent-control data are not present.

FAQs

1. How does payer placement for SGLT2 inhibitors typically change net revenue for fixed-dose metformin combinations?
2. What utilization management steps most often restrict new starts of SGLT2 + metformin fixed-dose products?
3. How do fixed-dose strength availability and titration pathways affect adherence and switching to competing SGLT2 combinations?
4. What indicators in pharmacy claims data best predict a branded SGLT2 combination’s share loss before generic entry?
5. How do safety communications and label updates usually alter SGLT2 class prescription trends?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).

DrugChatter Q&A for SEGLUROMET

Segluromet france commercialise?
Segluromet non commercialise en france?
Segluromet fda approval date?
Segluromet ema approval date?
Segluromet france commercialisation?