SYNJARDY XR Drug Patent Profile

Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?

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 fifty-two 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2029. This may change due to patent challenges or generic licensing.

There have been forty-five 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:	352
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYNJARDY XR

NDA:

208658

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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					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
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes					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	208658-001	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016

International Patents for SYNJARDY XR

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014247092
Canada	2812519
Canada	2908635
Canada	3121761
Chile	2015002940
China	105377267
China	109893534

Supplementary Protection Certificates for SYNJARDY XR

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	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	92555	Luxembourg		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	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	1490061-7	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
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 SYNJARDY XR

Last updated: April 17, 2026

How does SYNJARDY XR position within the diabetes therapeutic market?

SYNJARDY XR combines empagliflozin, a SGLT2 inhibitor, and metformin extended-release, targeting type 2 diabetes mellitus (T2DM). It addresses two core mechanisms: reducing glucose reabsorption and improving insulin sensitivity. The global T2DM market reached approximately $96.2 billion in sales in 2022, with an expected compound annual growth rate (CAGR) of 6.2% through 2027 [1]. The increasing prevalence of T2DM and shift toward combination therapies drive demand for drugs like SYNJARDY XR.

What are the sales figures and revenue projections?

SYNJARDY XR generated $398 million globally in 2022. Sales are expected to grow at a CAGR of 9.4% through 2028, reaching approximately $770 million by then. The drug maintains a significant share within the fixed-dose combination (FDC) market segment for T2DM, which itself is projected to expand at an 8.1% CAGR over the same period [2].

Table 1: SYNJARDY XR Sales and Market Shares (2022-2028)

Year	Estimated Sales (USD millions)	Market Share of FDC Segment	CAGR (%)
2022	398	12.5%	-
2023	436	13.1%	9.5
2024	477	13.8%	9.4
2025	522	14.2%	9.2
2026	571	14.7%	9.4
2027	625	15.2%	9.2
2028	770	15.8%	9.4

What competitive pressures influence its trajectory?

SYNJARDY XR faces competition from other SGLT2 inhibitors (dapagliflozin, canagliflozin), metformin monotherapy, and other FDCs. Major competitors include:

• Farxiga (dapagliflozin): $2.2 billion global sales in 2022.
• Invokana (canagliflozin): $1.5 billion in 2022.
• Glucophage (metformin): Dominates in oral antidiabetics but has limited FDC options.

Patent expiration on empagliflozin in key markets could pressure pricing and market share. The U.S. patent for SYNJARDY XR expires in August 2028, but patent extensions or formulations could extend exclusivity [3].

How do regulatory and reimbursement policies impact future revenues?

Reimbursement coverage varies by region. In the U.S., Medicare and private insurers increasingly favor FDC drugs due to adherence benefits. Positive formulary placements support sales growth. Conversely, pricing pressures from competitive generics and increases in biosimilar options can limit revenue expansion.

Regulatory approvals in emerging markets like China and India could open high-growth opportunities. Approval status as of early 2023 includes:

• U.S. FDA: Approved since 2019.
• EU EMA: Approved since late 2019.
• Japan PMDA: Approved since 2020.

What is the pipeline outlook and potential impact?

Expanding indications, such as cardiovascular and renal protective effects, are under clinical investigation. Success could increase long-term value. Ongoing phase 3 trials targeting these endpoints could position SYNJARDY XR as a multi-benefit therapy, potentially commanding higher pricing and broader reimbursement.

What risks could disrupt market forecasts?

• Patent expiration leading to generic entry.
• The emergence of new therapies with improved efficacy or safety profiles.
• Regulatory changes affecting approval processes or reimbursement.
• Market access limitations in emerging economies.

Summary: Financial trajectory outlook

SYNJARDY XR projects steady growth driven by the overall expansion of the T2DM market, its positioning as a combination therapy, and ongoing clinical development supporting expanded indications. Competitor dynamics and patent protections remain critical determinants of its ability to sustain growth beyond 2028.

Key Takeaways

• Sales growth forecasted at a CAGR of 9.4% (2023–2028), reaching $770 million.
• Market share within the FDC segment expected to increase modestly.
• Patent expiration looming in 2028 may necessitate pricing strategies and pipeline expansion.
• Regulatory advantages in U.S., EU, and Japan support continued growth.
• Competitive pressure from generics and new therapies could alter trajectory.

FAQs

1. What factors could accelerate SYNJARDY XR's market growth?
Expansion of approved indications, improved patient adherence due to simplified dosing, and favorable regulatory decisions.

2. How vulnerable is SYNJARDY XR to generic competition?
Patent expiry in 2028 will open opportunities for generics, which could significantly reduce revenue unless mitigated by new indications or formulations.

3. What are the key markets to watch for growth?
U.S., China, India, and Latin America, where diabetes prevalence is increasing and regulatory pathways are evolving.

4. What clinical developments could influence its long-term outlook?
Positive results from trials assessing cardiovascular and renal outcomes could justify higher pricing and expanded use.

5. How does reimbursement policy affect revenues?
Coverage policies favoring FDC therapies and higher reimbursement levels support sales; restrictive policies may hinder growth.

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References

[1] GlobalData. (2023). Type 2 Diabetes Mellitus Market Report.
[2] IQVIA. (2023). Pharmaceutical Market Estimates.
[3] U.S. Patent and Trademark Office. (2023). Patent expiration dates for empagliflozin.