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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-two 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 thirteen 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:	372
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
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
Genuine Research Center, Egypt	Phase 1
Hikma Pharma	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 twelve 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	208658-002	Dec 9, 2016		RX	Yes	No	11,833,166
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	11,833,166
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No	12,263,153

International Patents for SYNJARDY

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

Country	Patent Number	Title	Estimated Expiration
Canada	2606650	FORME CRISTALLINE DE 1-CHLORO-4-(.BETA.-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, SON PROCEDE DE PREPARATION ET SON UTILISATION DANS LA PREPARATION DE MEDICAMENTS (CRYSTALLINE FORM OF 1-CHLORO-4-(.BETA.-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS)
Japan	5685550
Argentina	087208	FORMA CRISTALINA DE 1-CLORO-4-(b-D-GLUCOPIRANOS-1-IL)-2-[4-((S)-TETRAHIDROFURAN-3-ILOXI)-BENCIL]-BENCENO, UN METODO PARA SU PREPARACION Y EL USO DEL MISMO PARA PREPARAR MEDICAMENTOS
Finland	2981255

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
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	C 2014 039	Romania		PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522

Market Dynamics and Financial Trajectory of SYNJARDY

Introduction to SYNJARDY

SYNJARDY, a combination of empagliflozin and metformin, is a significant player in the antidiabetic drug market. Developed by Boehringer Ingelheim and Eli Lilly and Company, this medication is designed to manage type 2 diabetes by combining the benefits of an SGLT2 inhibitor (empagliflozin) and a biguanide (metformin).

Market Context of Antidiabetic Drugs

The global antidiabetic drugs market is experiencing robust growth, driven by increasing diabetes prevalence, advances in medical research, and improved healthcare access. The market size was estimated at USD 82.37 billion in 2023 and is expected to expand at a CAGR of 12.23% from 2024 to 2030[3].

Segment Dominance: GLP-1 Receptor Agonists and SGLT2 Inhibitors

While GLP-1 receptor agonists dominated the market in 2023 with a share of 35.96%, SGLT2 inhibitors like empagliflozin are also gaining significant traction. The combination of empagliflozin with metformin in SYNJARDY leverages the efficacy of both drug classes, making it a competitive product in the market[4].

Sales and Revenue Trends

The sales of SYNJARDY, although not explicitly broken down in recent reports, can be inferred from the overall performance of empagliflozin-based products. For instance, Eli Lilly's new products, including those related to empagliflozin (such as Jardiance and Synjardy), contributed significantly to their revenue growth. In Q4 2023, Eli Lilly's new products revenue grew by $2.19 billion to $2.49 billion, with Mounjaro and other products like Jardiance driving this growth[2][5].

Market Share and Utilization

The market share of SYNJARDY is influenced by its inclusion in various national and international formularies. In Canada, for example, the sales of empagliflozin, which include both Jardiance and Synjardy, have shown substantial growth. The report by the Patented Medicine Prices Review Board (PMPRB) indicates that the sales of empagliflozin and its combinations have been increasing over the years, reflecting its growing market share[1].

Impact of Provincial and National Policies

Provincial biosimilar switching policies and other healthcare regulations can significantly impact the market dynamics of antidiabetic drugs. For instance, policies that favor the use of biosimilars or generic versions of antidiabetic medications can affect the sales of branded products like SYNJARDY. However, the unique combination of empagliflozin and metformin in SYNJARDY often makes it a preferred choice despite these policies[1].

Competitive Landscape

The antidiabetic market is highly competitive, with several major players including Eli Lilly, Boehringer Ingelheim, Sanofi, and Novo Nordisk. The acquisition of Provention Bio by Sanofi, for example, highlights the ongoing efforts by companies to diversify and strengthen their diabetes portfolios. SYNJARDY competes directly with other combination therapies and innovative antidiabetic drugs, necessitating continuous innovation and marketing efforts to maintain market share[3].

Regional Market Performance

The performance of SYNJARDY varies across different regions. In North America, which accounts for the highest market share of antidiabetic drugs, SYNJARDY benefits from strong healthcare infrastructure and high prescription rates. In Europe, the high prevalence of diabetes and government initiatives to improve public health also drive the demand for innovative antidiabetic drugs like SYNJARDY[3][4].

Technological Advancements and R&D

Advances in medical research and technology are crucial for the growth of the antidiabetic market. The introduction of new drug delivery systems and the development of generic variants, such as Dr. Reddy's Laboratories' Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, keep the market dynamic and competitive. SYNJARDY's efficacy and safety profile, backed by robust clinical research, contribute to its market position[3].

Patient Adherence and Awareness

Increased awareness of diabetes management and early intervention have boosted patient adherence to therapies. SYNJARDY's combination therapy makes it easier for patients to manage their condition with a single medication, enhancing adherence and contributing to its market success[3].

Financial Performance of Eli Lilly

Eli Lilly's financial results provide insight into the performance of SYNJARDY. The company's revenue increased by 28% in Q4 2023, with new products, including those related to empagliflozin, driving this growth. The net income and earnings per share also saw significant increases, reflecting the strong financial trajectory of Eli Lilly's antidiabetic portfolio[2][5].

Future Outlook

The future outlook for SYNJARDY is promising, given the expanding antidiabetic market and the drug's competitive positioning. The Asia Pacific region, expected to grow at the fastest rate during the forecast period, presents a significant opportunity for SYNJARDY. Additionally, the shift towards online pharmacies and the growing demand for subcutaneous administration methods are trends that SYNJARDY can leverage to maintain its market presence[4].

Key Takeaways

• Market Growth: The global antidiabetic market is expected to expand significantly, driven by increasing diabetes prevalence and advances in medical research.
• Segment Dominance: GLP-1 receptor agonists and SGLT2 inhibitors are key segments, with SYNJARDY benefiting from its combination therapy.
• Sales and Revenue: SYNJARDY contributes to the growing revenue of Eli Lilly, driven by its inclusion in new product portfolios.
• Market Share: Provincial and national policies, along with competitive landscape, influence SYNJARDY's market share.
• Regional Performance: Strong performance in North America and Europe, with growth opportunities in the Asia Pacific region.
• Technological Advancements: Continuous innovation in drug delivery and generic variants keeps the market competitive.
• Patient Adherence: Increased awareness and early intervention boost patient adherence to SYNJARDY.

FAQs

What is SYNJARDY, and how does it work?

SYNJARDY is a combination of empagliflozin (an SGLT2 inhibitor) and metformin (a biguanide), designed to manage type 2 diabetes by reducing blood sugar levels through different mechanisms.

How does SYNJARDY fit into the global antidiabetic market?

SYNJARDY is part of the growing antidiabetic market, which is expected to expand at a CAGR of 12.23% from 2024 to 2030. It competes in the SGLT2 inhibitor segment, which is gaining traction.

What are the key drivers of SYNJARDY's market success?

Key drivers include increasing diabetes prevalence, advances in medical research, improved healthcare access, and high patient adherence due to its combination therapy.

How does SYNJARDY perform in different regions?

SYNJARDY performs well in North America and Europe, with significant growth opportunities in the Asia Pacific region due to increasing healthcare infrastructure and government initiatives.

What are the future trends that could impact SYNJARDY's market position?

Future trends include the growth of online pharmacies, increasing demand for subcutaneous administration methods, and ongoing technological advancements in drug delivery systems.

Sources

1. Market Intelligence Report: Antidiabetic Drugs, 2012-2021. Canada.ca.
2. Lilly Reports Strong Fourth-Quarter 2023 Financial Results and .... Eli Lilly and Company.
3. Antidiabetics Market Size, Share And Growth Report, 2030. Grand View Research.
4. Antidiabetics Market Size to Reach USD 263.12 Billion by 2033. BioSpace.
5. Lilly Reports Strong Fourth-Quarter 2023 Financial Results and .... PR Newswire.

Last updated: 2024-12-16