SYNJARDY Drug Patent Profile

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

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are fifteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SYNJARDY 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

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

There have been thirty-eight 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

International Patents:	377
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for SYNJARDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY
What excipients (inactive ingredients) are in SYNJARDY?	SYNJARDY excipients list
DailyMed Link:	SYNJARDY at DailyMed

See drug prices for SYNJARDY

Recent Clinical Trials for SYNJARDY

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

Sponsor	Phase
Gedeon Richter Plc.	PHASE1
Humanis Saglık Anonim Sirketi	PHASE1
Genuine Research Center, Egypt	Phase 1

See all SYNJARDY clinical trials

Pharmacology for SYNJARDY

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

Paragraph IV (Patent) Challenges for SYNJARDY

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

US Patents and Regulatory Information for SYNJARDY

SYNJARDY is protected by thirteen 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	208658-001	Dec 9, 2016		RX	Yes	No	9,949,997*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No	10,596,120*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes	10,610,489*PED				Y

International Patents for SYNJARDY

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2018011088
Croatia	P20240752
China	103467423	Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof

Supplementary Protection Certificates for SYNJARDY

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
1730131	568	Finland
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SYNJARDY

Last updated: September 24, 2025

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Introduction

Synjardy (empagliflozin and metformin hydrochloride) is an oral antidiabetic medication developed and marketed by Boehringer Ingelheim and Eli Lilly. Approved by the FDA in 2015, Synjardy is indicated for adults with type 2 diabetes mellitus inadequately controlled on metformin alone. Its unique combination of an SGLT2 inhibitor (empagliflozin) with metformin positions it within a competitive landscape driven by rapidly evolving diabetes management therapies. This report delineates the current market dynamics influencing Synjardy’s trajectory and provides insights into its future financial prospects within the broader pharmaceutical landscape.

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Market Overview and Demand Drivers

The global type 2 diabetes mellitus (T2DM) therapeutics market is forecast. According to IQVIA, the market was valued at approximately $57 billion in 2022, with an annual growth rate of around 7% (CAGR 2022-2027). The surge in demand is primarily fueled by increasing prevalence rates, changing lifestyles, and expanding therapeutic options targeting glycemic control and cardiometabolic events.

Key Demand Drivers:

• Rising Prevalence of T2DM: The International Diabetes Federation estimates over 537 million adults worldwide suffered from diabetes in 2021, projected to reach 643 million by 2030. This relentless rise expands the patient population eligible for drugs like Synjardy.
• Innovative Therapeutic Profile: Synjardy’s dual mechanism—combining SGLT2 inhibition with metformin—addresses multiple pathogenic pathways, enhancing glycemic control and offering additional benefits such as weight loss and blood pressure reduction.
• Guideline Endorsements: American Diabetes Association (ADA) guidelines increasingly recommend SGLT2 inhibitors for patients with high cardiovascular risk, positioning Synjardy favorably among combination therapies.
• Convenience and Adherence: Fixed-dose combinations improve patient compliance by reducing pill burden, indirectly boosting market penetration.

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Competitive Landscape

Synjardy operates within a highly competitive environment characterized by various classes of oral antidiabetic agents.

Main Competitors Include:

• Other SGLT2 inhibitors: Farxiga (dapagliflozin), Invokana (canagliflozin), and Jardiance (empagliflozin as monotherapy) serve as direct competitors, with Jardiance being notable due to its cardiovascular benefits.
• GLP-1 receptor agonists: Ozempic (semaglutide), Trulicity (dulaglutide). While injectable, these drugs are increasingly preferred for cardiovascular risk reduction.
• Traditional oral agents: Sulfonylureas, DPP-4 inhibitors, and insulin therapies remain standard, though they face declining growth due to side effects and newer options.

Market Positioning: Synjardy’s combination therapy benefits patients who require more aggressive glycemic management with a favorable safety and tolerability profile. However, the expanding use of newer classes, especially GLP-1 receptor agonists, challenges its market share.

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Regulatory and Clinical Factors

Regulatory decisions significantly influence Synjardy’s trajectory:

• Cardiovascular Outcomes: The CVOT trial EMPA-REG OUTCOME demonstrated empagliflozin’s cardiovascular benefits, fostering confidence in its class and increasing prescription rates.
• Label Expansion: Regulatory approvals for additional indications or updated labeling emphasizing cardiovascular benefits may enhance Synjardy's appeal.
• Safety Profile: Concerns around genitourinary infections (SGLT2 class effect) and rare adverse events could temper adoption, requiring vigilant post-market surveillance.

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Financial Trajectory and Revenue Forecast

The financial outlook for Synjardy hinges on multiple factors:

• Market Penetration: As of 2022, Synjardy’s global sales were estimated to be in the low hundreds of millions USD, with growth potential constrained by competition and patent protections.
• Pricing Strategies: Premium pricing persists, especially with added benefits; however, cost pressures and formulary negotiations could erode margins.
• Patent Status and Generics: The loss of patent exclusivity—expected around 2024—may precipitate generic competition, severely impacting revenue.
• Combination Strategies: Boehringer Ingelheim and Eli Lilly are exploring partnerships, formulations, and expanded indications to sustain sales.
• Market Expansion: Emerging markets present significant growth opportunities, driven by expanding healthcare infrastructure and increasing diabetes prevalence.

Projected Revenue Trajectory: Analysts project a peak revenue potential for Synjardy in the range of $300-500 million annually in the next 3-5 years if market conditions remain favorable. However, impending patent expiry and escalating competition threaten to moderate growth and accelerate generic erosion.

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Market Risks and Opportunities

Risks Include:

• Patent Expiry: The imminent patent expiration threatens to commoditize Synjardy, leading to revenue decline unless protected by new formulations or indications.
• Competitive Innovation: Rapid advances in biotherapeutics and combination modalities could sideline traditional oral agents.
• Regulatory Hurdles: Stringent post-market safety requirements may impose additional costs or restrict use.

Opportunities Encompass:

• Expanding Indications: Exploring cardiovascular, renal, or weight-management indications could diversify revenue streams.
• Formulation Improvements: Developing once-weekly or injectable formulations may enhance adherence.
• Market Penetration Efforts: Targeted strategies in emerging markets and underserved populations can boost sales.
• Digital Health Integrations: Utilizing telemedicine and digital adherence tools offers potential for patient engagement and improved outcomes.

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Conclusion

Synjardy’s market trajectory is shaped by a confluence of robust demand for effective diabetes therapies, intense competition, and impending patent expiration. Its current financial performance reflects solid sales within a dynamic environment, with future growth contingent upon strategic differentiation, expanded indications, and landscape navigation. The increasing prevalence of T2DM worldwide reinforces the long-term potential, provided Boehringer Ingelheim and Eli Lilly adapt to evolving clinical and market conditions.

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Key Takeaways

• The global T2DM market’s steady growth underpins Synjardy’s commercial relevance, yet intensified competition and patent risks necessitate strategic agility.
• Synjardy leverages a dual mechanism that appeals to patients with complex glycemic needs; however, shifting prescribing patterns favor newer classes like GLP-1 receptor agonists.
• Patent expiry around 2024 represents a critical inflection point, with generics likely to erode revenues unless diversified or reformulated.
• Expanding indications and emerging markets present viable avenues for sustaining revenue streams.
• Continuous monitoring of regulatory landscapes, safety profiles, and competitive innovations is essential for optimized market positioning.

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FAQs

1. What distinguishes Synjardy from other antidiabetic medications?
Synjardy combines empagliflozin, an SGLT2 inhibitor, with metformin in a fixed-dose formulation—providing dual action for glycemic control, along with additional benefits such as weight reduction, blood pressure lowering, and cardiovascular risk mitigation.

2. How does the upcoming patent expiry impact Synjardy’s market?
Patent expiration around 2024 is expected to introduce generic versions, significantly reducing prices and sales unless the manufacturer develops new formulations or acquires additional indications to extend market exclusivity.

3. Are there recent regulatory developments that affect Synjardy?
Regulatory bodies emphasize cardiovascular safety and expanded indications for SGLT2 inhibitors, which can influence approval and labeling strategies. No recent restrictions specifically target Synjardy but ongoing safety monitoring is vital.

4. What are the main competitive threats to Synjardy?
Key threats include newer oral agents, especially GLP-1 receptor agonists with cardiovascular benefits, and other combination therapies under development. Patent expiration also presents a major competitive challenge.

5. What strategic actions can prolong Synjardy’s market viability?
Expanding indications, improving formulations, exploring combination regimens, and penetrating emerging markets can enhance longevity. Investment in digital health tools could further differentiate the product.

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References

1. IQVIA. Global Pharma Market Reports 2022-2027.
2. International Diabetes Federation. IDF Diabetes Atlas, 2021.
3. American Diabetes Association. Standards of Medical Care in Diabetes—2022.
4. Boehringer Ingelheim. Synjardy Product Monograph.
5. U.S. Food and Drug Administration. FDA Label for Synjardy.