~ Buy the SYNJARDY XR (empagliflozin; metformin hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-one 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 fourteen 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:	251
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4
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
Hikma Pharma	Phase 1
Genuine Research Center, Egypt	Phase 1

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 eleven 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	208658-004	Dec 9, 2016		RX	Yes	Yes	12,115,179
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No	7,579,449*PED				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	10,258,637*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes

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	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	208658-004	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
Croatia	P20120627
Hungary	E050287
Spain	2314743
Japan	4226070
China	105377267	Therapeutic uses of empagliflozin

Supplementary Protection Certificates for SYNJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
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	C01730131/05	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1730131	200 5026-2014	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527

SYNJARDY XR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SYNJARDY XR

Introduction

SYNJARDY XR, a combination of empagliflozin and metformin hydrochloride, is a significant treatment option for adults with type 2 diabetes. Approved by the U.S. FDA in 2016, this medication is marketed by Boehringer Ingelheim and Eli Lilly and Company. Here, we will delve into the market dynamics and financial trajectory of SYNJARDY XR.

Market Need and Demand

Type 2 diabetes is a prevalent condition, affecting approximately 29 million Americans and an estimated 415 million people worldwide. Nearly 28% of Americans with diabetes are undiagnosed, highlighting the ongoing need for effective treatments[1].

Mechanism of Action and Clinical Significance

SYNJARDY XR combines empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide. Empagliflozin works by removing excess glucose through the urine, while metformin lowers glucose production by the liver and its absorption in the intestine. This dual mechanism makes SYNJARDY XR an effective adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes[1][3].

FDA Approval and Clinical Trials

The FDA approval of SYNJARDY XR was based on multiple clinical trials that examined the co-administration of empagliflozin and metformin, either alone or in combination with other medications like sulfonylurea. These trials demonstrated the efficacy of SYNJARDY XR in improving blood sugar levels in adults with type 2 diabetes[1].

Safety and Side Effects

While SYNJARDY XR is effective, it also comes with serious side effects, including lactic acidosis, dehydration, low blood pressure, and increased ketones in the blood. Lactic acidosis, a rare but serious condition, is a medical emergency that requires hospital treatment[1][3].

Market Competition

The diabetes treatment market is highly competitive, with various medications and combination therapies available. SYNJARDY XR competes with other SGLT2 inhibitors and combination therapies, but its unique dual-action mechanism and convenience of a single daily dose make it a compelling option for many patients.

Financial Performance

Revenue and Sales

SYNJARDY XR is part of Eli Lilly and Company's portfolio, which has seen significant growth in recent years. While specific revenue figures for SYNJARDY XR are not isolated, the overall performance of Lilly's diabetes portfolio, including other key products like Jardiance (which contains empagliflozin), has been strong. In Q1 2024, Lilly reported a 26% increase in worldwide revenue, driven in part by the success of its diabetes treatments[5].

Pricing and Cost

The pricing of SYNJARDY XR varies based on the dosage and packaging. For example, the average pharmacy cost for SYNJARDY XR 5-1000 MG tablets is around $9.78 per unit, with bulk purchases often reducing the cost per unit[4].

Market Impact

The financial trajectory of SYNJARDY XR is influenced by its market impact. As a convenient daily option that combines two effective diabetes medications, it has attracted a significant patient base. The partnership between Boehringer Ingelheim and Eli Lilly has been instrumental in marketing and distributing the drug, contributing to its financial success.

Key Growth Drivers

Patient Convenience

SYNJARDY XR offers patients a convenient once-daily dosing regimen, which can improve adherence to treatment plans. This convenience is a key driver of its market success, as it simplifies the treatment regimen for adults with type 2 diabetes[1].

Clinical Efficacy

The drug's efficacy in improving glycemic control and its complementary mechanisms of action make it a preferred choice for many healthcare providers. Clinical trials have demonstrated its effectiveness, which has contributed to its market acceptance[1][3].

Regulatory Environment

The FDA approval and subsequent updates to the drug's labeling have ensured that SYNJARDY XR remains a viable treatment option. Regulatory support and the absence of major safety concerns have helped maintain its market position.

Challenges and Opportunities

Side Effects and Safety Concerns

Despite its efficacy, SYNJARDY XR's potential for serious side effects, such as lactic acidosis, presents a challenge. Managing these risks through proper patient selection and monitoring is crucial for maintaining its market standing[1][3].

Market Competition and Innovation

The diabetes treatment market is dynamic, with continuous innovation and the introduction of new therapies. SYNJARDY XR must compete with newer treatments and combination therapies, which can impact its market share.

Expanding Indications

While SYNJARDY XR is not currently indicated for reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, ongoing research and potential future indications could expand its market[3].

Financial Projections and Guidance

Eli Lilly and Company's financial guidance for 2024 reflects strong revenue growth, driven in part by its diabetes portfolio. The company has raised its full-year revenue guidance, indicating a positive financial trajectory for its key products, including those related to SYNJARDY XR[5].

Conclusion

SYNJARDY XR has established itself as a significant player in the type 2 diabetes treatment market due to its dual-action mechanism, convenience, and clinical efficacy. Despite challenges such as potential side effects and market competition, its financial trajectory remains positive, driven by strong patient demand and the robust performance of Eli Lilly and Company's diabetes portfolio.

Key Takeaways

• Combination Therapy: SYNJARDY XR combines empagliflozin and metformin, offering a dual-action mechanism for improving glycemic control.
• Market Demand: High demand due to the prevalence of type 2 diabetes and the need for effective treatments.
• Clinical Efficacy: Demonstrated efficacy in clinical trials, making it a preferred choice for many healthcare providers.
• Safety Concerns: Potential for serious side effects like lactic acidosis, which must be managed carefully.
• Financial Performance: Part of Eli Lilly and Company's strong diabetes portfolio, contributing to overall revenue growth.
• Market Competition: Faces competition from other diabetes treatments but remains a viable option due to its convenience and efficacy.

FAQs

What is SYNJARDY XR used for?

SYNJARDY XR is used as an adjunct to diet and exercise to improve blood sugar levels in adults with type 2 diabetes when both empagliflozin and metformin can be taken.

What are the main components of SYNJARDY XR?

SYNJARDY XR is a combination of empagliflozin, an SGLT2 inhibitor, and metformin hydrochloride, a biguanide.

What are the potential side effects of SYNJARDY XR?

Potential side effects include lactic acidosis, dehydration, low blood pressure, and increased ketones in the blood.

Is SYNJARDY XR approved for type 1 diabetes or diabetic ketoacidosis?

No, SYNJARDY XR is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.

Who markets SYNJARDY XR?

SYNJARDY XR is marketed by Boehringer Ingelheim and Eli Lilly and Company.

Sources

1. U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. PR Newswire.
2. Lilly Reports Fourth-Quarter 2022 Financial Results, Core Business. Eli Lilly and Company.
3. SYNJARDY XR. FDA.
4. Drug prices and trends for SYNJARDY. DrugPatentWatch.
5. Lilly Reports First-Quarter 2024 Financial Results and Raises Full-Year Guidance. Eli Lilly and Company.