Ertugliflozin; metformin hydrochloride - Generic Drug Details

What are the generic sources for ertugliflozin; metformin hydrochloride and what is the scope of freedom to operate?

Ertugliflozin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin; metformin hydrochloride has eighty-six patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for ertugliflozin; metformin hydrochloride

International Patents:	86
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ertugliflozin; metformin hydrochloride
DailyMed Link:	ertugliflozin; metformin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ertugliflozin; metformin hydrochloride

Constraining patent/regulatory exclusivity:

9,308,204

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 ertugliflozin; metformin hydrochloride

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

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 4
Merck Sharp & Dohme Corp.	Phase 4
Pfizer	Phase 3

See all ertugliflozin; metformin hydrochloride clinical trials

Pharmacology for ertugliflozin; metformin hydrochloride

Drug Class

Biguanide

Anatomical Therapeutic Chemical (ATC) Classes for ertugliflozin; metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ertugliflozin; metformin hydrochloride

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	209806-003	Dec 19, 2017		RX	Yes	No	9,308,204		Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No	9,439,902
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No

EU/EMA Drug Approvals for ertugliflozin; metformin hydrochloride

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/004314 Segluromet 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 ertugliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	103497199	Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives
South Africa	201203486	DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Japan	5696156

Supplementary Protection Certificates for ertugliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
2334687	2018/028	Ireland		PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
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

Ertugliflozin; metformin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ertugliflozin/Metformin Hydrochloride

Introduction

Ertugliflozin/metformin hydrochloride, marketed as Segluromet, is a fixed-dose combination (FDC) drug used to treat type 2 diabetes. This article delves into the market dynamics and financial trajectory of this medication, highlighting its efficacy, cost implications, and market positioning.

Efficacy and Clinical Benefits

Glycemic Control

Studies have shown that adding ertugliflozin to metformin significantly reduces HbA1c levels in patients with type 2 diabetes. In four main studies involving over 3,600 patients, ertugliflozin plus metformin resulted in HbA1c reductions of around 0.8 to 0.9 percentage points compared to placebo or other treatments[3][4].

Additional Health Benefits

Apart from glycemic control, ertugliflozin/metformin FDC has been associated with reductions in body weight and risk of heart failure. These additional benefits enhance its value in the treatment of type 2 diabetes[4].

Noninferiority to Other Treatments

Ertugliflozin 15 mg daily, when combined with metformin, has been shown to be noninferior to glimepiride in reducing HbA1c levels over 52 weeks. However, the 5 mg dose did not meet the noninferiority criteria against glimepiride[1].

Market Positioning

Competitive Landscape

The diabetes treatment market is highly competitive, with various classes of drugs including SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas, and others. Ertugliflozin/metformin FDC competes directly with other SGLT2/metformin combinations and individual components of these drugs[2].

Cost-Effectiveness

The cost-minimization analysis (CMA) conducted by the manufacturer indicates that ertugliflozin/metformin FDC represents a cost-effective option compared to other SGLT2/metformin FDCs and the individual components. It generates savings of up to $0.68 per day compared to other SGLT2/metformin FDCs and between $0.38 to $2.90 per day compared to co-administered SGLT2 and metformin[2].

Financial Trajectory

Pricing and Cost Savings

The daily cost of ertugliflozin/metformin FDC is approximately $2.45, which is priced similarly to other SGLT2/metformin FDCs. However, it offers cost savings due to reduced dispensing fees and the inclusion of metformin at no additional cost. This pricing strategy makes it a competitive option in the market[2].

Budget Impact Analysis

Budget impact analyses suggest that the reimbursement of ertugliflozin/metformin FDC would be cost-neutral to cost-saving for drug plans. It would not result in a greater number of claims or patients treated, thereby maintaining a stable financial impact on healthcare systems[2].

Comparative Costs

While ertugliflozin/metformin FDC is more costly than older second- and third-line drugs combined with metformin, it is less costly than newer second- and third-line drugs in combination with metformin. However, there is uncertainty regarding its comparative effectiveness against all relevant comparators, which complicates definitive cost conclusions[1].

Market Dynamics

Patient and Payer Preferences

The combination of ertugliflozin and metformin in a single tablet enhances patient compliance and convenience, which can be a significant factor in market preference. Payers also benefit from the cost savings associated with reduced dispensing fees and the optimal daily dose of metformin included in the FDC[2].

Regulatory and Patent Status

The exclusivity for both ertugliflozin and the ertugliflozin/metformin FDC is based on the ertugliflozin compound patent, which expires in August 2029. This patent status influences the market dynamics by limiting generic competition during this period[2].

Challenges and Limitations

Uncertainty in Comparative Efficacy

There is substantial uncertainty regarding the comparative efficacy of ertugliflozin/metformin FDC against other diabetes treatments. This uncertainty affects the ability to draw definitive conclusions on its cost-effectiveness and market positioning[1].

Variability in Public Prices

Public prices for antidiabetic drugs vary across jurisdictions, and there may be confidential prices negotiated, which adds complexity to the financial analysis and market dynamics[2].

Key Takeaways

• Efficacy: Ertugliflozin/metformin FDC is effective in reducing HbA1c levels, body weight, and the risk of heart failure.
• Cost-Effectiveness: It offers cost savings compared to other SGLT2/metformin FDCs and individual components.
• Market Positioning: Competes directly with other SGLT2/metformin combinations and individual components.
• Financial Trajectory: Represents a cost-effective option with potential for cost-neutral to cost-saving impact on drug plans.
• Challenges: Uncertainty in comparative efficacy and variability in public prices across jurisdictions.

FAQs

Q: What are the primary benefits of using ertugliflozin/metformin FDC in treating type 2 diabetes?

A: The primary benefits include significant reductions in HbA1c levels, body weight, and the risk of heart failure.

Q: How does the cost of ertugliflozin/metformin FDC compare to other diabetes treatments?

A: It is priced similarly to other SGLT2/metformin FDCs but offers cost savings due to reduced dispensing fees and the inclusion of metformin at no additional cost.

Q: What is the regulatory and patent status of ertugliflozin/metformin FDC?

A: The exclusivity is based on the ertugliflozin compound patent, which expires in August 2029.

Q: Are there any uncertainties in the market dynamics of ertugliflozin/metformin FDC?

A: Yes, there is uncertainty regarding its comparative efficacy against other diabetes treatments and variability in public prices across jurisdictions.

Q: How does ertugliflozin/metformin FDC impact patient compliance and payer preferences?

A: The combination in a single tablet enhances patient compliance and convenience, and payers benefit from cost savings associated with reduced dispensing fees.

Sources

1. NCBI: Ertugliflozin/Metformin Fixed-Dose Combination (Segluromet) - NCBI
2. NCBI: Pharmacoeconomic Evaluation - NCBI Bookshelf - NCBI
3. EMA: Segluromet (ertugliflozin / metformin hydrochloride) - EMA
4. EMA: Segluromet | European Medicines Agency (EMA)
5. EMA: STEGLATRO, INN-ertugliflozin - European Medicines Agency