EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Empagliflozin; linagliptin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin; metformin hydrochloride has four hundred and eighty-five patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

International Patents:	485
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Dosage:

TABLET, EXTENDED RELEASE;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 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Medanta, The Medicity, India	N/A
The First Affiliated Hospital with Nanjing Medical University	N/A
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	N/A

See all EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
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

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIJARDY XR	Extended-release Tablets	empagliflozin; linagliptin; metformin hydrochloride	5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g	212614	1	2020-05-26

US Patents and Regulatory Information for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No					Y

Expired US Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020

International Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	103450129	Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof
South Africa	200701996	Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines
Japan	2009079061	8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINE, ITS PREPARATION AND ITS USE AS PHARMACOLOGICAL COMPOSITION

Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	62/2014	Austria		PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527
1532149	C01532149/01	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1532149	C20110018 00046	Estonia		PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug Combination: Empagliflozin, Linagliptin, and Metformin Hydrochloride

Introduction

The combination of empagliflozin, linagliptin, and metformin hydrochloride, marketed as Trijardy XR, represents a significant advancement in the treatment of type 2 diabetes (T2D). This article delves into the market dynamics and financial trajectory of this triple fixed-dose combination (FDC), highlighting its efficacy, safety, and economic implications.

Efficacy and Safety of the Combination

Clinical Outcomes

Studies have consistently shown that the combination of empagliflozin, linagliptin, and metformin hydrochloride offers superior glycemic control compared to individual components or dual therapies. For instance, Phase 3 studies demonstrated significant reductions in HbA1c, fasting plasma glucose (FPG), and body weight when this combination was added to metformin background therapy[3][4][5].

HbA1c Reduction

The combination therapy resulted in substantial reductions in HbA1c levels. In one study, the addition of linagliptin to empagliflozin and metformin led to HbA1c reductions of up to 1.45% from baseline at week 24, with efficacy maintained at week 52[2][3].

Weight Loss and Hypoglycemia Risk

Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is known for its weight-loss benefits. The combination therapy also showed a low risk of hypoglycemic episodes, making it a favorable option for patients with uncontrolled T2D[5].

Market Dynamics

Growing Demand for T2D Treatments

The global market for T2D treatments is expanding due to the increasing prevalence of diabetes. The introduction of new-generation drugs like SGLT2 inhibitors and DPP-4 inhibitors has driven market growth. The combination of empagliflozin, linagliptin, and metformin hydrochloride taps into this demand by offering a convenient and effective treatment option[1].

Competitive Landscape

The T2D market is highly competitive, with various drug classes and combinations available. However, the triple FDC of empagliflozin, linagliptin, and metformin hydrochloride stands out due to its comprehensive glycemic control and additional benefits such as weight loss and low hypoglycemia risk. This unique profile positions Trijardy XR as a competitive player in the market[4].

Regulatory Approvals

The FDA approval of Trijardy XR in 2020 marked a significant milestone. The approval was based on extensive clinical data demonstrating the bioequivalence, efficacy, and safety of the combination. This regulatory backing has bolstered the drug's market presence and credibility[3][4].

Financial Trajectory

Cost-Effectiveness

Despite being a combination therapy, Trijardy XR is cost-effective compared to purchasing individual components. A 30-day supply of Trijardy XR costs approximately $555, which is more economical than buying separate tablets of empagliflozin, linagliptin, and metformin, which could total over $1,000[5].

Market Sales

The sales data for empagliflozin and other new-generation antidiabetic drugs have shown significant growth. For example, sales of empagliflozin, including its combinations with metformin, have been on the rise since its introduction. The addition of linagliptin to this combination is expected to further boost sales due to its enhanced efficacy and convenience[1].

Revenue Projections

Given the strong clinical data and favorable market dynamics, revenue projections for Trijardy XR are optimistic. The drug is expected to capture a substantial share of the growing T2D market, driven by its comprehensive benefits and cost-effectiveness.

Patient and Payer Perspectives

Patient Compliance

The convenience of a single tablet containing three active ingredients can improve patient compliance. This is particularly important for T2D management, where adherence to medication regimens is crucial for maintaining glycemic control[4].

Payer Acceptance

Payers are increasingly looking for cost-effective treatments that offer significant clinical benefits. The combination of empagliflozin, linagliptin, and metformin hydrochloride aligns with these criteria, making it more likely to be included in formularies and reimbursement lists[5].

Challenges and Opportunities

Regulatory and Safety Considerations

While the combination has been shown to be safe and effective, there are contraindications, such as severe renal impairment, that need to be considered. Continuous monitoring of safety data and adherence to regulatory guidelines will be essential for maintaining market trust[5].

Expanding Indications

There is potential for expanding the indications of Trijardy XR to other patient populations or for use in combination with other therapies. Ongoing research and clinical trials could uncover new opportunities for this drug combination.

Key Takeaways

• Efficacy: The combination of empagliflozin, linagliptin, and metformin hydrochloride offers superior glycemic control, weight loss, and a low risk of hypoglycemia.
• Market Dynamics: The growing demand for T2D treatments and the competitive landscape position Trijardy XR as a significant player.
• Financial Trajectory: The drug is cost-effective and expected to generate substantial revenue due to its comprehensive benefits.
• Patient and Payer Perspectives: Improved patient compliance and payer acceptance are anticipated due to the convenience and cost-effectiveness of the combination.
• Challenges and Opportunities: Continuous safety monitoring and potential expansion of indications are key areas to focus on.

FAQs

Q: What are the primary components of Trijardy XR?

A: Trijardy XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride.

Q: What are the key clinical benefits of Trijardy XR?

A: The combination offers significant reductions in HbA1c, FPG, and body weight, along with a low risk of hypoglycemia.

Q: Is Trijardy XR cost-effective?

A: Yes, Trijardy XR is more cost-effective than purchasing the individual components separately.

Q: What are the contraindications for Trijardy XR?

A: Trijardy XR is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m^2).

Q: Has Trijardy XR been approved by regulatory authorities?

A: Yes, Trijardy XR was approved by the FDA in 2020 based on extensive clinical data demonstrating its bioequivalence, efficacy, and safety.

Sources

1. MARKET INTELLIGENCE REPORT - Canada.ca
2. Combination of Empagliflozin and Linagliptin as Second-Line Therapy - Diabetes Care
3. 212614Orig1s000 - FDA
4. Triple fixed-dose combination empagliflozin, linagliptin, and metformin XR - Tandfonline
5. Trijardy XR Generic Name: empagliflozin, linagliptin, and metformin hydrochloride extended-release tablets - WVU Pharmacy