STEGLATRO Drug Patent Profile

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

Steglatro is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Steglatro

Steglatro 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 December 19, 2031. 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 STEGLATRO

International Patents:	61
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	4
Patent Applications:	916
Drug Prices:	Drug price information for STEGLATRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLATRO
What excipients (inactive ingredients) are in STEGLATRO?	STEGLATRO excipients list
DailyMed Link:	STEGLATRO at DailyMed

See drug prices for STEGLATRO

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

Constraining patent/regulatory exclusivity:

8,080,580

NDA:

209803

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 STEGLATRO

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

Sponsor	Phase
Wilhelminenspital Vienna	Phase 3
Klinikum Wiener Neustadt	Phase 3
General Hospital Linz	Phase 3

See all STEGLATRO clinical trials

Paragraph IV (Patent) Challenges for STEGLATRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STEGLATRO	Tablets	ertugliflozin	5 mg and 15 mg	209803	3	2021-12-20

US Patents and Regulatory Information for STEGLATRO

STEGLATRO is protected by one US patents.

This potential generic entry date is based on patent 8,080,580.

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	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017		RX	Yes	No	8,080,580		Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017		RX	Yes	Yes	8,080,580		Y	Y

EU/EMA Drug Approvals for STEGLATRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Steglatro	ertugliflozin	EMEA/H/C/004315Steglatro 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:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.	Authorised	no	no	no	2018-03-21

International Patents for STEGLATRO

When does loss-of-exclusivity occur for STEGLATRO?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 STEGLATRO around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2728
Argentina	073138
Austria	E540040
Australia	2009286380
Brazil	PI0918841
Canada	2733795
Chile	2011000394

Supplementary Protection Certificates for STEGLATRO

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
2334687	PA2018510	Lithuania		PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687	CA 2018 00025	Denmark		PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687	30/2018	Austria		PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323

STEGLATRO (ertugliflozin) Market Dynamics and Financial Trajectory: Pricing, Volume Drivers, Exclusivity Timeline, and Competitive Pressure

Last updated: July 22, 2026

Executive summary: STEGLATRO (ertugliflozin) revenue trajectory has been shaped by SGLT2 inhibitor category growth, rapid uptake versus DPP-4 inhibitors, and intensifying competition from higher-share agents in the class. The product’s near-term financial outlook depends on (1) category share migration within SGLT2, (2) label expansion adoption, and (3) payer formulary strategy as additional generics and biosimilar-free substitutes emerge across the class. Patent and exclusivity posture matters for “when” generic risk arrives; however, the key market dynamic is share competition, not a single binary exclusivity event, because multiple SGLT2 competitors held larger installed bases and broader managed-care coverage.

What are the key market dynamics driving STEGLATRO (ertugliflozin) sales growth and decline?

STEGLATRO’s market performance is best understood as a function of SGLT2 inhibitor category substitution economics: once payers and prescribers establish a preferred SGLT2, new entrants face reimbursement friction and slower share ramp. STEGLATRO’s competitive hurdle is that the SGLT2 class consolidated around agents with the largest prescriber adoption, strongest payer relationships, and the most durable safety-and-outcomes narrative in managed care.

How do SGLT2 pricing and payer restrictions shape STEGLATRO net sales?

SGLT2 net pricing is typically pressured by:

• formulary placement tiers (preferred vs non-preferred)
• rebate intensity tied to contracting and volume commitments
• step edits or prior authorization for naïve patients
• brand-to-brand competition that accelerates “best net” convergence

For STEGLATRO, this means commercial results are sensitive to whether it is “preferred” in large PBMs and integrated delivery networks. A shift from preferred to non-preferred often produces a visible volume step-down, even if list price remains stable.

What patient segments drive volume for STEGLATRO?

Volume drivers in SGLT2 are concentrated in:

• type 2 diabetes (T2D) patients needing glycemic control with weight and BP benefits
• patients with high cardiovascular risk profiles, where outcomes benefits influence selection
• patients with established heart failure (HF) or CKD, where cross-indication adoption raises persistence

STEGLATRO’s growth ceiling depends on how effectively it converts these segment needs into “first-choice” prescribing under payer constraints.

What are the main competitive forces within SGLT2 inhibitor class?

The SGLT2 market is dominated by agents that built earlier market momentum and have entrenched formulary positions. Competition typically plays out across three levers:

• formulary share: which agent is preferred for new starts
• switch behavior: whether clinicians move stable patients when contracting changes
• outcomes perception: how prescribers interpret event reductions, safety, and real-world tolerability

STEGLATRO’s share dynamics are most exposed when payers consolidate around fewer preferred SKUs.

How does STEGLATRO compare with Jardiance and Farxiga on market position and share?

Competition among SGLT2 inhibitors is usually a contest for managed-care preferred status. Although all agents share the same general mechanism, the commercialization outcomes differ due to:

• earlier adoption timing
• depth of payer contracting
• downstream indication breadth adoption (cardio-renal vs glycemic-only early use)

What does “class leadership” mean commercially for STEGLATRO?

“Class leadership” translates to higher persistence, lower discontinuation, and higher formulary stability. When an agent is the default preferred option, it captures:

• a higher share of new-to-class initiations
• more straightforward continuation without repeated prior authorization
• lower channel inventory volatility because volume is forecastable

A non-leading agent must instead win through payer-specific exceptions, targeted prescriber panels, and patient-specific rationale. That structure compresses the upside for STEGLATRO unless contracting improves.

Where does STEGLATRO have defensible positioning?

STEGLATRO’s commercial defensibility tends to come from:

• patient-specific factors that make clinicians comfortable using ertugliflozin within an established SGLT2 strategy
• adoption tied to existing continuity-of-care patterns
• localized payer relationships that maintain formulary access

The risk is that when payers simplify preferred lists, a non-leading brand faces immediate share erosion.

What is STEGLATRO’s revenue trajectory and margin profile versus the SGLT2 category?

STEGLATRO’s revenue trajectory in mature branded markets typically follows a pattern seen with less entrenched branded SGLT2 products:

• ramp during early adoption
• stabilization as the agent reaches payer threshold “coverage”
• deceleration as preferred-contract consolidation intensifies

How do rebates and channel mix affect STEGLATRO financial outcomes?

SGLT2 economics are rebate-heavy because:

• PBM and payer contracts drive net price below list
• brand-to-brand switching increases rebate escalation pressure
• channel inventory swings can distort near-quarter reported revenue

Even if gross demand remains stable, net revenue can fall when:

• rebates increase to maintain preferred position
• effective price drops due to contracting “give-backs”
• wholesalers adjust inventory levels

When does STEGLATRO lose exclusivity and what generic entry risks exist?

The generic entry timeline is determined by patent expiration and regulatory exclusivity periods (including new chemical entity and any data exclusivity for specific indications), plus the Paragraph IV litigation cadence if ANDA challenges occur.

Which patents protect STEGLATRO and what matters for generic timing?

For an exclusivity and generic-timing analysis, the operative question is whether the ANDA applicant can design around:

• composition-of-matter coverage
• formulation and salt/polymorph coverage (if applicable)
• method-of-use claims for T2D and any cardio-renal label expansions

In practice, STEGLATRO’s generic risk is driven by the strength and remaining life of:

• active ingredient composition claims
• any blocking patents covering clinical use or specific dosing regimens
• any listed Orange Book patents tied to the approved product

How do Paragraph IV challenges translate into market impact?

If a Paragraph IV ANDA is filed with an asserted claim carve-out, settlement often triggers:

• delayed launch until a later date
• launch at risk only if the brand loses litigation
• post-settlement entry windows that can stagger generic availability

For branded market share, the key point is launch timing. If generics enter on schedule, net price erosion accelerates; if delayed, branded revenue sustains longer.

What is the Orange Book status of STEGLATRO (ertugliflozin) and which patent listings are most relevant to a generic switch?

Orange Book status determines whether FDA-listed patents can block immediate generic approval (or delay with FDA carve-outs and litigation risk). The actionable items are:

• list of Orange Book patent numbers tied to the approved drug
• patent expiration dates
• whether patents are “listed” for the same NDA strength and dosage form

How many patents cover STEGLATRO and how strong is the likely generic design-around path?

Generic applicants typically target the easiest-to-design-around coverage, often focusing on non-composition claims if composition-of-matter patents are not yet expired. The practical strength measure is:

• remaining life across core patents
• number of separately listed blocking patents
• whether method-of-use patents exist for the relevant indication strength

What formulation and method-of-use IP risks matter for STEGLATRO generics?

Even when composition patents expire, secondary layers can affect launch:

• method-of-use claims for diabetes control, cardiovascular outcomes, heart failure, and CKD-related endpoints (where separately protected)
• manufacturing or formulation process claims
• specific dose regimen claims that align with labeling

Are there dose-specific or regimen-specific constraints that can delay generic substitution?

Where method-of-use or dosing regimen claims exist, FDA-approved labeling carve-outs can allow approval while restricting marketing claims. That creates a slower real-world adoption curve, even after legal entry.

What STEGLATRO patent litigation affects market timing and settlement outcomes?

Patent litigation shapes generic entry via:

• preliminary injunctions
• stay orders during appeal
• negotiated settlements that define “skinny labels” and launch dates

What settlement mechanisms are common in STEGLATRO-style SGLT2 disputes?

Settlements commonly include:

• agreed launch dates
• non-infringement covenants tied to claim-specific design
• stipulations on forfeiture or timing of subsequent amendments

The market impact is usually determined by whether settlement triggers an early carve-out (faster generic uptake) or a delayed launch with broader labeling restrictions.

How does FDA regulatory status and label expansion affect STEGLATRO financial performance?

SGLT2 sales are tightly linked to label adoption in real-world practice:

• increased eligibility broadens prescriber willingness
• expands persistence through chronic indications
• increases payers’ ability to justify coverage under cardio-renal programs

Which label areas most influence prescribing behavior?

Commercial adoption often accelerates when:

• outcomes labels support cardiovascular and renal risk management
• HF and CKD indications strengthen the justification to switch from competing classes
• dosing simplicity supports formulary committees’ policy work

What generic entry scenarios are most likely for STEGLATRO and when could they impact revenue?

Two scenarios dominate:

1. Full launch after expiry: generic entry at earliest legally permitted date causes sharp net price decline and rapid share loss.
2. Carve-out launch after settlement: generics enter earlier on restricted labeling, producing slower share transfer and more brand-like persistence.

In both cases, the magnitude depends on payer switching policies. Payers may prefer a single SGLT2 for coverage, so entering generics among multiple SGLT2 brands can shift substitution dynamics.

How does STEGLATRO’s competitive landscape evolve if SGLT2 generics enter while brand contracts remain?

If multiple SGLT2 products face generic entry around similar periods, payers often standardize:

• preferred brand-to-generic transitions
• narrower formularies to simplify contracting
• bundling across diabetes and cardio-renal management

STEGLATRO’s residual revenue resilience in such a scenario depends on whether it retains “last brand standing” positioning in managed care while peers face faster brand erosion.

Key Takeaways

• STEGLATRO’s financial trajectory is dominated by SGLT2 class contracting dynamics, not isolated exclusivity milestones.
• Revenue sensitivity is highest to formulary preferred status, rebate intensity, and persistence driven by cardio-renal label uptake.
• Generic risk timing depends on Orange Book blocking patents and litigation/settlement schedules that govern whether launch occurs at the earliest expiry or via delayed settlements.
• Competitive share pressure from larger entrenched SGLT2 competitors increases exposure to payer consolidation that narrows preferred lists.

FAQs

1. How do prior authorization and step edits affect STEGLATRO new-start volume versus preferred SGLT2 competitors?
2. What is the typical difference in net price between a non-preferred branded SGLT2 and its preferred class peer?
3. Do STEGLATRO method-of-use patent carve-outs allow faster generic entry with slower real-world substitution?
4. How do label expansions in heart failure and CKD change persistence for STEGLATRO in managed care?
5. What settlement terms most influence when STEGLATRO generics can market full versus limited-label indications?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Search STEGLATRO / ertugliflozin).
2. U.S. Food and Drug Administration. Drug Approval Package: STEGLATRO (ertugliflozin).
3. FDA Orange Book patent listings and related Federal Register notices for relevant exclusivity and patent term information.

DrugChatter Q&A for STEGLATRO

The patent period of steglatro?
Steglatro loss of exclusivity?
Steglatro ertugliflozine france commercialisation?