SYNJARDY XR Drug Patent Profile

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

Summary for SYNJARDY XR

International Patents:	340
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for SYNJARDY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY XR
DailyMed Link:	SYNJARDY XR at DailyMed

See drug prices for SYNJARDY XR

Recent Clinical Trials for SYNJARDY XR

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Gedeon Richter Plc.	PHASE1
Humanis Saglık Anonim Sirketi	PHASE1

See all SYNJARDY XR clinical trials

Pharmacology for SYNJARDY XR

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

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	11,833,166*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	12,263,153
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	9,949,997*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No	9,949,997*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	12,427,162
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	12,115,179*PED				Y

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	208658-004	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016	6,488,962
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016	6,488,962

International Patents for SYNJARDY XR

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

Country	Patent Number	Title	Estimated Expiration
Argentina	048041	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, COMPOSICIONES FARMACEUTICAS Y PROCEDIMIENTO PARA SU PREPARACION
Canada	3121761
Spain	2797503
Israel	218714	GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF
Uruguay	32441	COMPOSICION FARMACEUTICA, METODOS DE TRATAMIENTO Y SUS USOS
South Korea	20150138859	엠파글리플로진의 치료적 용도 (THERAPEUTIC USES OF EMPAGLIFLOZIN)
New Zealand	711661	Therapeutic uses of empagliflozin

Supplementary Protection Certificates for SYNJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	1490061-7	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131	CR 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131	C01730131/03	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	2014/055	Ireland		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

Market Dynamics and Financial Trajectory for SYNJARDY XR

Last updated: July 28, 2025

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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.

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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].

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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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