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Last Updated: April 14, 2025

EMPAGLIFLOZIN - Generic Drug Details


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

Empagliflozin is the generic ingredient in seven branded drugs marketed by Zydus Pharms and Boehringer Ingelheim, and is included in seven NDAs. There are twenty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has three hundred and twenty-three patent family members in forty-six countries.

There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Summary for EMPAGLIFLOZIN
Recent Clinical Trials for EMPAGLIFLOZIN

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 1/Phase 2
Diabetes CanadaPhase 4
Rigshospitalet, DenmarkPhase 4

See all EMPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free5MG;1000MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try for Free⤷  Try for Free25MG;5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free25MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EMPAGLIFLOZIN
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JARDIANCE Tablets empagliflozin 10 mg and 25 mg 204629 14 2018-08-01

US Patents and Regulatory Information for EMPAGLIFLOZIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

EU/EMA Drug Approvals for EMPAGLIFLOZIN

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Boehringer Ingelheim International GmbH Jardiance empagliflozin EMEA/H/C/002677
Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease. 
Authorised no no no 2014-05-22
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

International Patents for EMPAGLIFLOZIN

CountryPatent NumberTitleEstimated Expiration
Argentina 077513 DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS, SU APLICACION Y PROCEDIMIENTO PARA SU PREPARACION ⤷  Try for Free
Australia 2019202568 ⤷  Try for Free
Hong Kong 1213818 依帕列淨的治療用途 (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Try for Free
Japan 2018131448 ⤷  Try for Free
Morocco 31612 COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE BENZENE SUBSTITUE PAR GLUCOPYRANOSYLE ⤷  Try for Free
South Africa 200705883 ⤷  Try for Free
South Korea 20110118786 PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for EMPAGLIFLOZIN

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2187879 122017000024 Germany ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
1730131 1490061-7 Sweden ⤷  Try for Free PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
2187879 1790019-2 Sweden ⤷  Try for Free PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
2187879 20/2017 Austria ⤷  Try for Free PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
2187879 2017/018 Ireland ⤷  Try for Free PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
2187879 CA 2017 00019 Denmark ⤷  Try for Free PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
1730131 CR 2014 00054 Denmark ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory for Empagliflozin

Market Size and Growth

The market for empagliflozin, along with other SGLT2 inhibitors like dapagliflozin and canagliflozin, has been experiencing steady growth. As of 2023, the market size was valued at $9.41 billion and is projected to reach $9.64 billion in 2024, with a compound annual growth rate (CAGR) of 2.4%[1][3].

By 2028, the market is expected to grow to $10.78 billion at a CAGR of 2.8%, driven by increasing demand for oral diabetes medications, growing investments in diabetes research, increased healthcare spending, and a greater emphasis on combination therapies[1][3].

Drivers of Market Growth

Several factors are driving the growth of the empagliflozin market:

  • Increasing Prevalence of Type 2 Diabetes: The global rise in type 2 diabetes cases is a significant driver, as more patients require effective treatment options[1][3].
  • Awareness of SGLT2 Inhibitors: Greater awareness among healthcare providers and patients about the benefits of SGLT2 inhibitors, such as empagliflozin, is boosting demand[1][3].
  • Aging Population: The growth in the elderly population, who are more prone to diabetes and related complications, is another key factor[1][3].
  • Obesity Rates: Increasing obesity rates, which are closely linked to the development of type 2 diabetes, also contribute to market growth[1][3].
  • Personalized Medicine: A heightened focus on personalized medicine is leading to more tailored treatment approaches, including the use of empagliflozin[1][3].

Financial Impact and Cost Savings

The financial impact of incorporating empagliflozin into treatment regimens is multifaceted:

  • Drug Acquisition Costs: While the addition of empagliflozin increases drug acquisition costs, it also leads to significant savings in other areas. For example, in Malaysia, the total cost with empagliflozin rose by 0.71%, but this was offset by savings from reduced heart failure hospitalizations, fewer cardiovascular deaths, and improved renal outcomes[2].
  • Savings from Reduced Hospitalizations: Studies have shown that empagliflozin can reduce heart failure hospitalizations, leading to substantial cost savings. In one analysis, the reduction in hospitalizations contributed to 62.6% of the cost savings[2].
  • Cost Savings from Reduced Cardiovascular Deaths and Renal Outcomes: Empagliflozin also results in cost savings from reduced cardiovascular deaths and improved renal outcomes. For instance, in Malaysia, the average annual savings from these improvements were significant, offsetting a large portion of the increased drug costs[2].

Budget Impact Analysis

A budget impact analysis conducted from the perspective of the Malaysian Ministry of Health highlighted that the addition of empagliflozin to guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) requires a net annual investment but is largely compensated by cost savings from clinical improvements.

  • Key Factors Influencing Budget Impact: The analysis identified the cost of empagliflozin, expenses associated with heart failure hospitalizations, and the incidence of cardiovascular mortality as key factors influencing the budget impact. A 20% reduction in the price of empagliflozin could result in significant cost savings[2].

Regional Market Dynamics

The empagliflozin market is segmented across various regions, each with its own dynamics:

  • North America: This region was the largest market for empagliflozin, dapagliflozin, and canagliflozin in 2023. The market here is driven by high healthcare spending and a large patient population[3].
  • Asia-Pacific: This region is expected to see significant growth due to the increasing prevalence of diabetes and growing healthcare investments[1][3].
  • Europe: Both Western and Eastern Europe are important markets, with growth influenced by demographic changes, healthcare policies, and economic conditions[1][3].

Trends and Strategies

Several trends and strategies are shaping the empagliflozin market:

  • Technological Advancements: Continuous advancements in technology are improving the efficacy and safety of SGLT2 inhibitors[1][3].
  • Combination Therapies: There is a growing emphasis on combination therapies, which include empagliflozin, to provide more comprehensive treatment options for patients with diabetes and related conditions[1][3].
  • Telehealth and Health Data Analytics: The integration of telehealth services and health data analytics is enhancing patient care and treatment outcomes, further driving the market[1][3].
  • Patient Data Security: With the increasing use of digital health technologies, ensuring patient data security is becoming a critical focus area[1][3].

Competitive Landscape

The market for empagliflozin is competitive, with several major pharmaceutical companies involved:

  • Market Shares: Companies like Boehringer Ingelheim and Eli Lilly, which market empagliflozin under the brand name Jardiance, hold significant market shares. Other companies, such as AstraZeneca and Janssen, also play important roles with their respective SGLT2 inhibitors[1][3].

Macro Economic Scenario

The market is influenced by various macroeconomic factors:

  • Impact of High Inflation: High inflation can affect the affordability and accessibility of empagliflozin, particularly in regions with stringent healthcare budgets[1].
  • Ukraine-Russia War: The conflict has impacted supply chains and economic stability in Eastern Europe, affecting the overall market dynamics[1][3].
  • COVID-19 Impact: The pandemic has accelerated the adoption of telehealth and health data analytics, but it has also posed challenges in terms of supply chain disruptions and altered demand patterns[1][3].

Key Takeaways

  • The empagliflozin market is growing steadily, driven by increasing demand for oral diabetes medications and growing awareness of SGLT2 inhibitors.
  • The market is expected to reach $10.78 billion by 2028, with a CAGR of 2.8%.
  • Empagliflozin offers significant cost savings through reduced hospitalizations, cardiovascular deaths, and improved renal outcomes.
  • Regional dynamics, technological advancements, and combination therapies are key trends shaping the market.
  • Macro-economic factors such as inflation, the Ukraine-Russia war, and the COVID-19 pandemic also influence market growth.

FAQs

Q: What is the current market size of empagliflozin, dapagliflozin, and canagliflozin?

The current market size of empagliflozin, dapagliflozin, and canagliflozin was $9.41 billion in 2023[1][3].

Q: What is the projected growth rate of the empagliflozin market?

The market is expected to grow at a CAGR of 2.8% from 2023 to 2028, reaching $10.78 billion by 2028[1][3].

Q: What are the key drivers of the empagliflozin market growth?

Key drivers include the increasing prevalence of type 2 diabetes, greater awareness of SGLT2 inhibitors, an expanding elderly population, increasing obesity rates, and a focus on personalized medicine[1][3].

Q: How does empagliflozin impact healthcare costs?

Empagliflozin can reduce healthcare costs through reduced heart failure hospitalizations, fewer cardiovascular deaths, and improved renal outcomes, offsetting the increased drug acquisition costs[2].

Q: What are the major trends shaping the empagliflozin market?

Major trends include technological advancements, combination therapies, telehealth, health data analytics, and enhanced patient data security[1][3].

Sources

  1. The Business Research Company, "Empagliflozin, Dapagliflozin And Canagliflozin Global Market Report 2024"
  2. PLOS ONE, "Evaluating the budget impact of Empagliflozin in managing heart failure with reduced ejection fraction"
  3. The Business Research Company, "Empagliflozin, Dapagliflozin And Canagliflozin Global Market Report 2024"
  4. Verified Market Research, "Empagliflozin Dapagliflozin And Canagliflozin Market Size, Scope"

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