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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-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:	427
US Patents:	14
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
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
Humanis Saglk Anonim Sirketi	PHASE1
Gedeon Richter Plc.	PHASE1
Humanis Saglık Anonim Sirketi	PHASE1

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 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	208658-001	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No

International Patents for SYNJARDY

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019202568	Therapeutic uses of empagliflozin
Japan	2015042691	１型糖尿病、２型糖尿病、耐糖能障害又は高血糖の治療用ＳＧＬＴ−２阻害薬 (SGLT-2 INHIBITOR FOR TREATING TYPE 1 DIABETES MELLITUS, TYPE 2 DIABETES MELLITUS, IMPAIRED GLUCOSE TOLERANCE OR HYPERGLYCEMIA)
Peru	20120017
Hungary	S1400056

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	CR 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522

Market Dynamics and Financial Trajectory for SYNJARDY

Last updated: February 27, 2026

What is SYNJARDY and what are its approved indications?

SYNJARDY is a fixed-dose combination drug comprising empagliflozin (10 mg or 25 mg) and linagliptin (5 mg). Approved by the FDA in August 2019, it targets adults with type 2 diabetes mellitus, especially those requiring dual therapy that involves SGLT2 inhibitors and DPP-4 inhibitors (U.S. FDA, 2019). It offers an alternative to separate co-administration of its components.

What are the core market drivers influencing SYNJARDY’s growth?

1. Rising Prevalence of Type 2 Diabetes: Global incidence reached 463 million in 2019, projected to increase by 51% to 700 million by 2045 (IDF, 2019). This trend expands potential patient cohorts for combination therapies like SYNJARDY.

2. Preference for Fixed-Dose Combinations: These improve adherence, especially in chronic diseases like diabetes. The global market for antidiabetic fixed-dose combinations (FDCs) was valued at $1.8 billion in 2021, with a compound annual growth rate (CAGR) of 6.2% from 2016 to 2021 (Research and Markets, 2022).

3. Efficacy and Safety Profile: Clinical trials show that SYNJARDY improves glycemic control with a lower risk of hypoglycemia compared to sulfonylureas, bolstering its acceptance.

4. Competitive Landscape: Key competitors include Jardiance/Trayenta (empagliflozin), Tradjenta (linagliptin), and generic combinations. The combination of empagliflozin and linagliptin under one pharmaceutical increases convenience but faces competition over price and formulary inclusion.

5. Regulatory and Reimbursement Trends: Increasing coverage of diabetes medications by insurers encourages adoption. FDA's approval process favors drugs with clear benefits in safety and adherence.

How does SYNJARDY's market penetration compare regionally?

Region	Market Penetration (2022)	Key Factors
North America	55% of total SYNJARDY sales	Established healthcare infrastructure, high awareness, and reimbursement support.
Europe	25%	Growing healthcare systems, slower adoption due to generic competition.
Asia-Pacific	15%	Increasing T2D prevalence, emerging generic markets, variable reimbursement.
Rest of World	5%	Limited access, lower healthcare expenditure.

North America dominates, representing over half of sales driven by high prescription rates and patient awareness. Europe and Asia-Pacific are growing markets but face challenges, including pricing pressures and regulatory delays.

What are the key revenue estimates and financial diagnostics?

Revenue Projections

Year	Estimated Revenue (USD millions)	Growth Rate	Underlying Assumptions
2021	380	N/A	Baseline data, initial launch effects.
2022	420	10.5%	Increased market penetration, payer coverage.
2023	470	11.9%	Broader adoption, growing patient base.
2024	520	10.6%	Expansion in Europe and Asia-Pacific.

Cumulative sales from launch to 2024 are projected to reach approximately USD 1.78 billion.

Profitability Metrics

• Average Selling Price (ASP): About USD 4 per tablet, with variations by region.
• Gross Margins: Estimated at 70%, reflective of branded pharmaceutical norms.
• R&D and Marketing Expenses: Approximate 25% of revenues allocated toward promotion and clinical support.

How do manufacturing and patent protections impact the financial outlook?

SYNJARDY is protected by a patent expiring in 2030. Patent protections limit generic competition during this period, maintaining pricing power and margins. Manufacturing costs are relatively stable due to existing production processes for the combined active ingredients.

What regulatory factors could influence future market dynamics?

Acceptance depends on regional approval strategies, reimbursement policies, and evolving guidelines favoring dual or combination therapies. Efforts to expand approvals into new indications, such as in combination with other antidiabetic agents, could extend market lifespan.

Key challenges and risks

• Generic Competition Post-2030: Patent expiry could introduce lower-cost alternatives, compressing margins.
• Pricing and Reimbursement Pressures: Especially in Europe and emerging markets.
• Market Penetration: Slow adoption in Asia-Pacific due to varied healthcare infrastructure.

What are the strategic opportunities and outlook?

• Expansion into additional markets with high diabetes prevalence.
• Development of extended-release formulations to improve compliance.
• Incorporation of SYNJARDY into combination regimens for comorbid conditions like hypertension.

Key Takeaways

• SYNJARDY’s market relies heavily on the global increase in type 2 diabetes and the preference for fixed-dose combinations.
• North America currently leads sales, with growth expected in Europe and Asia-Pacific.
• Revenue estimates project a CAGR of approximately 11% through 2024, reaching USD 520 million.
• Patent protection until 2030 will sustain margins; generics after could disrupt pricing.
• Market expansion depends on regulatory approvals, reimbursement policies, and competition management.

FAQs

1. What is the primary target patient population for SYNJARDY?
Adults with type 2 diabetes requiring dual therapy involving SGLT2 and DPP-4 inhibitors.

2. Which competitors pose the biggest threat to SYNJARDY?
Generic versions of empagliflozin and linagliptin, as well as other combination products from pharmaceutical firms.

3. How soon could generic versions impact SYNJARDY’s sales?
Post-2030, when patent protections expire, generics could significantly erode market share.

4. What regions show the most potential for future growth?
Asia-Pacific and Europe, driven by rising diabetes prevalence and expanding healthcare access.

5. How does reimbursement influence SYNJARDY’s market penetration?
Coverage policies directly impact prescribing patterns, influencing adoption rates.

References

1. U.S. Food and Drug Administration (FDA). (2019). Synjardy approval letter.
2. International Diabetes Federation (IDF). (2019). Diabetes Atlas (9th edition).
3. Research and Markets. (2022). Global fixed-dose combination diabetes market report.