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Last Updated: December 17, 2025

SYNJARDY XR Drug Patent Profile


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Which patents cover Synjardy Xr, and what generic alternatives are available?

Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and forty patent family members in forty-five countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Synjardy Xr

Synjardy Xr was eligible for patent challenges on August 1, 2018.

There have been forty-four 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

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Drug patent expirations by year for SYNJARDY XR
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Recent Clinical Trials for SYNJARDY XR

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

SponsorPhase
Gedeon Richter Plc.PHASE1
Humanis Saglık Anonim SirketiPHASE1
Hikma PharmaPhase 1

See all SYNJARDY XR clinical trials

Pharmacology for SYNJARDY XR
Paragraph IV (Patent) Challenges for SYNJARDY XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 SYNJARDY XR

SYNJARDY XR is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SYNJARDY XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 ⤷  Get Started Free ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SYNJARDY XR

See the table below for patents covering SYNJARDY XR around the world.

Country Patent Number Title Estimated Expiration
New Zealand 712106 Pharmaceutical composition, methods for treating and uses thereof ⤷  Get Started Free
Israel 287516 ⤷  Get Started Free
Canada 3175715 ⤷  Get Started Free
Lithuania 2981255 ⤷  Get Started Free
Hong Kong 1213820 包含 抑制劑、 抑制劑和任選的另種抗糖尿病藥的藥物組合物及其用途 (PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF SGLT2 DPP-IV) ⤷  Get Started Free
South Korea 20230074293 ⤷  Get Started Free
Japan 2016000756 メトホルミン及びDPP−4阻害剤又はSGLT−2阻害剤を含む医薬組成物 (PHARMACEUTICAL COMPOSITION COMPRISING METFORMIN AND DPP-4 INHIBITOR OR SGLT-2 INHIBITOR) ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYNJARDY XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/03 Switzerland ⤷  Get Started Free PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131 C01730131/04 Switzerland ⤷  Get Started Free PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1730131 PA2014035,C1730131 Lithuania ⤷  Get Started Free PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 2014/055 Ireland ⤷  Get Started Free PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 1490061-7 Sweden ⤷  Get Started Free PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
2187879 2017/018 Ireland ⤷  Get Started Free PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131 SPC/GB14/070 United Kingdom ⤷  Get Started 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

Market Dynamics and Financial Trajectory for SYNJARDY XR

Last updated: July 28, 2025


Introduction

SYNJARDY XR, a once-daily triple-combination therapy for managing type 2 diabetes mellitus (T2DM), has garnered significant attention within the pharmaceutical landscape. Combining empagliflozin (SGLT2 inhibitor), linagliptin (DPP-4 inhibitor), and extended-release metformin, SYNJARDY XR addresses the complex pathophysiology of T2DM with a comprehensive mechanism of action. This article examines the current market dynamics influencing SYNJARDY XR's commercial trajectory while projecting its financial prospects amid evolving therapeutic, regulatory, and competitive landscapes.


Market Overview and Therapeutic Context

Type 2 diabetes remains a global health crisis, with over 400 million individuals affected worldwide in 2023, projected to reach 550 million by 2030 [1]. The chronic nature of T2DM necessitates durable, effective, and well-tolerated treatment regimens, fostering an enduring demand for combination therapies like SYNJARDY XR.

The drug leverages the complementary effects of its components: empagliflozin reduces glucose reabsorption via renal SGLT2 inhibition, linagliptin enhances incretin activity, and extended-release metformin improves insulin sensitivity. This multimodal approach aligns with current guidelines favoring early combination therapy to improve glycemic control, reduce complications, and achieve durable remission [2].


Key Market Drivers

1. Rising Prevalence of T2DM

The accelerating global prevalence fuels demand for effective oral combination therapies. With emerging markets experiencing higher incidence rates linked to lifestyle transitions, the global demand for innovative treatments like SYNJARDY XR is set to expand significantly.

2. Preference for Fixed-Dose Combinations (FDCs)

FDCs improve adherence by reducing pill burden. SYNJARDY XR, with its once-daily dosing and proven efficacy, aligns well with this market preference. The convenience factor enhances patient compliance and, consequently, clinical outcomes.

3. Evolving Treatment Guidelines

Updated guidelines from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) endorse early combination therapy for T2DM management, increasing the utilization of drugs like SYNJARDY XR.

4. Competitive Advantages

Compared to monotherapies or dual combinations, SYNJARDY XR offers comprehensive glycemic control with a favorable safety profile, including cardiovascular benefits observed in clinical trials (e.g., EMPA-REG OUTCOME [3]). These attributes position it favorably against competitors.


Competitive Landscape

The core competitors include other triple or dual oral combination therapies, monotherapies, and emerging injectable options:

  • Dual-combination drugs such as Janumet (sitagliptin/metformin) and Xultophy (insulin degludec/liraglutide) continue to dominate.
  • Triple-combination therapies are gaining traction, with drugs like Trijardy XR (empagliflozin, linagliptin, extended-release metformin) directly competing in markets where SYNJARDY XR is available.
  • Innovative biotherapeutics such as GLP-1 receptor agonists and SGLT2 inhibitors are expanding not only as monotherapies but also as part of personalized, combination approaches.

Patent expirations and the entry of biosimilars pose risks, emphasizing the importance of ongoing innovation and lifecycle management for SYNJARDY XR.


Regulatory and Reimbursement Environment

Post-approval, SYNJARDY XR has secured pivotal regulatory clearances in various regions, including the U.S. and European Union. Reimbursement policies incentivize the use of combination drugs with proven efficacy, safety, and cardiovascular benefits. Payers increasingly favor drugs demonstrating improved patient outcomes, especially those reducing hospitalization and long-term complications.

However, pricing pressures and cost-containment strategies challenge profitability. Ensuring favorable reimbursement and demonstrating value through real-world evidence (RWE) remains critical to commercial success.


Financial Trajectory Analysis

1. Revenue Projections

Initial sales of SYNJARDY XR have thrived in markets with high T2DM prevalence and supportive healthcare infrastructure. Market penetration is projected to grow at a compound annual growth rate (CAGR) of approximately 8-12% over the next five years [4], driven by expanding indications, geography, and patient population.

2. Market Expansion Opportunities

  • Geographic Expansion: Entry into emerging markets (Asia-Pacific, Latin America) offers substantial growth potential, supported by increasing diabetes prevalence and unmet treatment needs.
  • Indication Expansion: Potential approval as a first-line combination or in populations with comorbid conditions (e.g., chronic kidney disease) can diversify the revenue base.

3. Cost and Pricing Dynamics

Pricing strategies will balance maximizing revenue with payer acceptance. Volume-driven growth is anticipated, though price erosion due to biosimilars, generics, and market competition will exert downward pressure.

4. Impact of Innovation and Pipeline Development

Potential pipeline candidates or line extensions could sustain long-term revenue streams. The integration of digital health initiatives and personalized medicine approaches offers avenues for new revenue channels.


Risks and Challenges

  • Market Saturation and Competition: Intense competition from other triple and dual therapies may limit market share.
  • Regulatory Changes: Stricter approval and reimbursement criteria could delay adoption.
  • Patent Litigation: Intellectual property challenges can influence exclusivity and profitability.
  • Clinical Adoption: Physicians' preferences for newer agents or monotherapies may impact market penetration.

Future Outlook and Strategic Considerations

To optimize financial outcomes, stakeholders should prioritize demonstrating SYNJARDY XR's long-term cardiovascular and renal benefits through RWE studies, which can influence formulary positioning and prescribing patterns. Enhancing patient adherence via digital engagement and expanding indications can further accelerate the drug’s market trajectory.

Strategic alliances, geographic expansion, and pipeline development will be essential. Companies must balance aggressive marketing with cost management to sustain profitability amid competitive pressures.


Key Takeaways

  • Growing Global Burden: The rising prevalence of T2DM underscores sustained demand for combination therapies like SYNJARDY XR.
  • Market Positioning: Its convenience, efficacy, and safety profile position it favorably against competing therapies.
  • Revenue Growth: Forecasted to grow at a CAGR of 8-12% over the next five years, driven by expanding indications and geographies.
  • Competitive Edge: Demonstrated cardiovascular benefits and adherence advantages offer differentiation opportunities, provided ongoing RWE supports this.
  • Risks & Opportunities: Market saturation and regulatory hurdles pose challenges; innovation and pipeline expansion remain critical for sustained growth.

FAQs

1. What is the primary therapeutic advantage of SYNJARDY XR?
It offers a fixed-dose, once-daily triple-combination therapy that improves glycemic control, reduces pill burden, and demonstrates cardiovascular benefits, aligning with current treatment guidelines favoring early combination therapy.

2. How does SYNJARDY XR compare economically to other T2DM therapies?
While initially higher in price than monotherapies, its convenience and improved adherence potentially lead to better long-term outcomes, reducing costly complications – factors that healthcare payers increasingly value.

3. What are the main barriers to SYNJARDY XR’s market growth?
Intense competition, pricing pressures, patent challenges, and clinician preferences for emerging therapies may limit market share expansion.

4. In which markets is SYNJARDY XR likely to experience the fastest growth?
Emerging markets in Asia-Pacific and Latin America, where diabetes prevalence is rising and access to combination therapies improves due to supportive infrastructure and increasing healthcare investments.

5. What future developments could influence SYNJARDY XR’s financial outlook?
Pipeline enhancements, new indications (e.g., renal protection), digital health integration, and demonstration of long-term benefits will be vital in maintaining competitive advantage and revenue growth.


References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2023.

[2] American Diabetes Association. Standards of Medical Care in Diabetes—2023. Diabetes Care 2023; Suppl 1.

[3] Zinman B, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. NEJM 2015;373(22):2117-2128.

[4] MarketWatch. “Global T2DM Drugs Market Forecast,” 2023.


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