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Last Updated: April 18, 2025

Empagliflozin; metformin hydrochloride - Generic Drug Details


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What are the generic sources for empagliflozin; metformin hydrochloride and what is the scope of patent protection?

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has three hundred and six patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for empagliflozin; metformin hydrochloride
Recent Clinical Trials for empagliflozin; metformin hydrochloride

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

SponsorPhase
Novo Nordisk A/SPhase 3
SINA Health Education and Welfare TrustPhase 2/Phase 3
Horizon Pharmaceutical Pvt LtdPhase 4

See all empagliflozin; metformin hydrochloride clinical trials

Pharmacology for empagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY Tablets empagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg 206111 4 2018-08-01
SYNJARDY XR Extended-release Tablets empagliflozin; metformin hydrochloride 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg 208658 3 2018-08-01

US Patents and Regulatory Information for empagliflozin; metformin hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No ⤷  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 XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Zydus Pharms EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE empagliflozin; metformin hydrochloride TABLET;ORAL 212198-004 Jul 7, 2022 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  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

Expired US Patents for empagliflozin; metformin hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for empagliflozin; metformin hydrochloride

CountryPatent NumberTitleEstimated Expiration
Canada 2908635 USAGES THERAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Try for Free
Cyprus 1109870 ⤷  Try for Free
Israel 241101 שימושים רפואיים באמפאגליפלוזין (Therapeutic uses of empagliflozin) ⤷  Try for Free
Lithuania 2981271 ⤷  Try for Free
Norway 339073 ⤷  Try for Free
South Korea 20210130844 엠파글리플로진의 치료적 용도 (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Try for Free
South Korea 101747152 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for empagliflozin; metformin hydrochloride

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1730131 1490061-7 Sweden ⤷  Try for Free PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131 568 Finland ⤷  Try for Free
1730131 92555 Luxembourg ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
1730131 C01730131/05 Switzerland ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1730131 C20140033 00134 Estonia ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131 PA2014035,C1730131 Lithuania ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 SPC/GB14/070 United Kingdom ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 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 and Metformin Hydrochloride

Introduction to Empagliflozin and Metformin Hydrochloride

Empagliflozin and metformin hydrochloride are key components in the treatment of type 2 diabetes, heart failure, and chronic kidney disease (CKD). Empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, works by reducing glucose reabsorption in the kidneys, while metformin hydrochloride is a well-established medication for lowering blood sugar levels. The combination of these two drugs has become a cornerstone in modern diabetes management.

Global Market Size and Growth

The global market for SGLT2 inhibitors, which includes empagliflozin, is projected to experience significant growth. As of 2023, the global SGLT2 inhibitors market was estimated at USD 15.85 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.71% from 2024 to 2030[1].

For empagliflozin tablets specifically, the market size was valued at USD 91.17 billion in 2023 and is projected to reach USD 176.51 billion by 2031, growing at a CAGR of 8.2% during the forecast period[3].

Key Drivers of Market Growth

Increasing Incidence of Type 2 Diabetes

The rising global incidence of type 2 diabetes is a primary driver of the market growth for empagliflozin and metformin hydrochloride. According to health organizations, millions of people worldwide are afflicted by diabetes each year, creating a high demand for effective treatments[3].

R&D and New Formulations

Continuous research and development (R&D) efforts have led to the development of new and improved formulations of SGLT2 inhibitors. For instance, the EMPACT-MI phase 3 clinical trial showed a 10% risk reduction in hospitalized heart failure patients after using empagliflozin, which is expected to boost demand for these drugs[1].

Positive Regulatory Environment

The favorable regulatory environment plays a crucial role in the market growth. The U.S. FDA and EMA have accelerated approval processes for new diabetes drugs that demonstrate clinical efficacy and safety. The recent approval of Jardiance (empagliflozin) for reducing cardiovascular mortality and CKD hospitalization further enhances market confidence[3].

Expanded Indications

Empagliflozin is not only used for type 2 diabetes but also for heart failure and CKD. Recent studies have shown that empagliflozin can lower hospitalization rates and improve cardiovascular outcomes, making it a valuable treatment option for a broader range of health issues[3].

Market Segments and Distribution Channels

Indication Outlook

The market for empagliflozin and metformin hydrochloride is segmented based on indications such as type 2 diabetes, cardiovascular diseases, and CKD. The treatment of type 2 diabetes remains the primary indication, but the drug's benefits in heart failure and CKD are increasingly recognized and driving growth[1].

Distribution Channels

The global market is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies are expected to play a significant role due to the rising presence of affordable drugs across these outlets[4].

Regional Outlook

North America

North America, particularly the U.S., is a significant market for empagliflozin and metformin hydrochloride. The region benefits from advanced healthcare infrastructure and high awareness of diabetes management, contributing to strong market growth[1].

Europe

Europe is another key region, with countries like Germany and France prioritizing cutting-edge diabetic therapies. The region's strong healthcare system and increasing disposable incomes support the market's expansion[3].

Asia-Pacific

The Asia-Pacific region is expected to experience major growth due to rising disposable incomes, better access to healthcare, and growing awareness of diabetes. Countries like China, Japan, and India are driving this growth[3].

Latin America and Middle East & Africa

Latin America is expected to expand due to increased healthcare efforts and a growing focus on lifestyle diseases. The Middle East and Africa present a varied landscape, with market growth influenced by differing levels of healthcare access and affordability[3].

Financial Trajectory

Revenue Projections

The financial trajectory for empagliflozin and metformin hydrochloride is positive, driven by strong patient demand and favorable regulatory approvals. The Jardiance segment, which includes empagliflozin, dominated the market with 52.60% of the global revenue in 2023 and is anticipated to grow significantly over the forecast period[1].

Key Milestones

  • Jardiance Achievements: Since its approval, Jardiance has achieved 59 million prescriptions worldwide and has contributed to extending patient lives by over 461,000 patient-life years[1].
  • Government Initiatives: The inclusion of Jardiance in the “Drug Price Negotiation Program” as part of the Inflation Reduction Act (IRA) by the Centers for Medicare and Medicaid Services (CMS) is expected to drive segment growth[1].

Challenges and Opportunities

Side Effects and Market Competition

Despite the positive financial trajectory, the market faces challenges such as potential side effects and market competition. However, strong patient demand and the drug's clinical efficacy continue to drive its financial success[5].

Customized Treatment Approaches

The emphasis on customized treatment approaches, including the use of empagliflozin for heart failure and CKD, presents significant opportunities for market growth. As healthcare frameworks prioritize disease management and patient quality of life, the adoption of SGLT2 inhibitors like empagliflozin is expected to increase[3].

Key Takeaways

  • The global market for SGLT2 inhibitors, including empagliflozin, is projected to grow significantly due to increasing incidence of type 2 diabetes and favorable regulatory environments.
  • Empagliflozin and metformin hydrochloride are key treatments for type 2 diabetes, heart failure, and CKD, with expanded indications driving market growth.
  • The market is segmented by indications and distribution channels, with retail pharmacies playing a crucial role.
  • Regional growth is driven by North America, Europe, and the Asia-Pacific region, with varying opportunities and challenges in Latin America and the Middle East & Africa.
  • The financial trajectory is positive, with strong patient demand and government initiatives supporting market expansion.

FAQs

Q: What is the projected market size for empagliflozin tablets by 2031?

The empagliflozin tablets market is projected to reach USD 176.51 billion by 2031, growing at a CAGR of 8.2% during the forecast period[3].

Q: What are the primary indications for empagliflozin and metformin hydrochloride?

The primary indications include type 2 diabetes, heart failure, and chronic kidney disease (CKD)[1][3].

Q: Which region is expected to experience major growth in the empagliflozin market?

The Asia-Pacific region is expected to experience major growth due to rising disposable incomes, better access to healthcare, and growing awareness of diabetes[3].

Q: What is the impact of government initiatives on the market for empagliflozin?

Government initiatives, such as the inclusion of Jardiance in the “Drug Price Negotiation Program” by CMS, are expected to drive segment growth and increase market confidence[1].

Q: How does the combination of empagliflozin and metformin hydrochloride benefit patients?

The combination benefits patients by regulating blood sugar levels, reducing glucose reabsorption in the kidneys, and providing additional benefits in heart failure and CKD management[2][3].

Sources

  1. Grand View Research: SGLT2 Inhibitors Market Size, Share & Growth Report, 2030.
  2. Synapse: Empagliflozin/metformin Hydrochloride - Drug Targets, Indications.
  3. Verified Market Research: Empagliflozin Tablets Market Size, Scope, Trends and Forecast.
  4. Fortune Business Insights: Diabetes Drugs Market Share, Growth | Global Report [2032].
  5. DrugPatentWatch: SYNJARDY XR Drug Patent Profile.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.