KOMBIGLYZE XR Drug Patent Profile

Which patents cover Kombiglyze Xr, and what generic alternatives are available?

Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in thirty-two countries.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Kombiglyze Xr

Kombiglyze Xr was eligible for patent challenges on July 31, 2013.

There have been 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 KOMBIGLYZE XR

International Patents:	57
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	3
Patent Applications:	209
Drug Prices:	Drug price information for KOMBIGLYZE XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KOMBIGLYZE XR
DailyMed Link:	KOMBIGLYZE XR at DailyMed

See drug prices for KOMBIGLYZE XR

Recent Clinical Trials for KOMBIGLYZE XR

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

Sponsor	Phase
University of Basrah	N/A
The University of Hong Kong	Phase 3
Karolinska Institutet	Phase 3

See all KOMBIGLYZE XR clinical trials

Pharmacology for KOMBIGLYZE XR

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Paragraph IV (Patent) Challenges for KOMBIGLYZE XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KOMBIGLYZE XR	Extended-release Tablets	metformin hydrochloride; saxagliptin hydrochloride	5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg	200678	3	2013-07-31

US Patents and Regulatory Information for KOMBIGLYZE XR

KOMBIGLYZE XR is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No	9,339,472		Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No	8,628,799		Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No	8,628,799		Y

Expired US Patents for KOMBIGLYZE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010	9,339,472
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010	6,395,767
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010	RE44186

International Patents for KOMBIGLYZE XR

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

Country	Patent Number	Title	Estimated Expiration
Montenegro	02643	FORMULACIJA I METOD OBLOŽENE TABLETE (COATED T ABLET FORMULATION AND METHOD)
Japan	2013040219	CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV AND METHOD
Canada	2568391	FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD)

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
1261586	SPC005/2010	Ireland		SPC005/2010: 20100702, EXPIRES: 20240930

Market Dynamics and Financial Trajectory for KOMBIGLYZE XR

Last updated: July 27, 2025

Introduction

KOMBIGLYZE XR (saxagliptin and metformin extended-release) is a prescription medication indicated for managing type 2 diabetes mellitus. Positioned within the burgeoning diabetic therapeutics market, KOMBIGLYZE XR’s market dynamics are influenced by evolving regulatory landscapes, patent protection status, competitive pressures, and shifting healthcare policies. This analysis examines its current market environment, growth potential, and overall financial outlook.

Market Overview and Demand Drivers

The global diabetes therapeutics market, valued at approximately USD 60 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of 7-8% over the next five years (Source: [1]). The rising prevalence of type 2 diabetes, driven by obesity, sedentary lifestyles, and aging populations, remains the primary demand catalyst.

KOMBIGLYZE XR enters as a fixed-dose combination (FDC) therapy, offering convenience and improved adherence, factors crucial in the diabetes management landscape. Its dual-action mechanism combines dipeptidyl peptidase-4 (DPP-4) inhibition with metformin's insulin-sensitizing effects. This positioning caters to patients inadequately controlled on monotherapy, expanding its addressable market segment.

Competitive Landscape

Major competitors include other FDCs and monotherapies, such as:

• JANUMET (sitagliptin and metformin)
• TRILYTA (linagliptin and metformin)
• DPP-4 inhibitors and SGLT2 inhibitors (e.g., Jardiance, Farxiga)
• GLP-1 receptor agonists

While KOMBIGLYZE XR benefits from patent protection and a strong brand presence, patent expirations for similar drugs pose risks of generic competition, impacting pricing and margins. Additionally, emerging therapies with novel mechanisms, like dual GIP/GLP-1 receptor agonists, pose long-term threats.

Regulatory Environment and Patent Status

KOMBIGLYZE XR was approved by the U.S. Food and Drug Administration (FDA) in 2014. Its patent life extends into the late 2020s, with patent extensions and formulation protections vital to maintaining exclusivity. The impending patent cliff could erode market share unless the manufacturer invests in new formulations, indications, or combination therapies.

Regulatory developments promoting biosimilar entry and cost-effectiveness evaluations (e.g., value-based pricing) influence market acceptance and reimbursement policies, particularly in Europe and other developed markets.

Market Penetration and Adoption Trends

KOMBIGLYZE XR’s adoption varies geographically, with higher penetration in North America and Western Europe owing to established healthcare infrastructure and prescribing habits favoring combination therapies. In emerging markets, growth hinges on affordability, local regulatory approvals, and infrastructure for chronic disease management.

Physician preferences favor drugs demonstrating superior glycemic control, safety profiles, and minimal side effects. KOMBIGLYZE XR’s tolerability and convenience are key drivers of prescription adoption, especially among patients intolerant to other therapies.

Pricing Strategies and Reimbursement

Pricing typically ranges between USD 300-500 per month for branded FDCs like KOMBIGLYZE XR. Reimbursement policies through insurance companies and national health services significantly influence sales volume. Favorable formulary placements and inclusion in clinical guidelines boost utilization.

Cost-containment pressures and the shift toward generic drugs threaten premium pricing strategies, demanding continued innovation and evidence of clinical superiority to justify premium prices.

Financial Trajectory and Growth Potential

The financial outlook for KOMBIGLYZE XR depends on multiple intertwined factors:

Revenue Projections

Assuming the current market share, an annual growth rate of 5-7% is plausible over the next 3-5 years, driven by increasing diabetes prevalence and improved adherence owing to its formulation.

Market Penetration Strategies

Pharmaceutical companies are investing in direct-to-consumer marketing, patient education, and physician awareness campaigns to expand utilization. Additionally, exploring new indications, such as cardiovascular risk reduction, can bolster sales.

Pipeline and Lifecycle Management

Efforts to extend patent life through secondary patents, formulation improvements, or combination with emerging drug classes will sustain revenues. Introducing next-generation formulations or indications (e.g., for prediabetes) could open new revenue streams.

Impact of Biosimilars and Generics

Generic versions of metformin and DPP-4 inhibitors threaten to erode margins post-patent expiration. Strategic planning involves diversification into novel therapies and capturing niche markets during patent exclusivity.

Emerging Market Dynamics

Growth in emerging markets depends on local healthcare reforms, affordability, and infrastructure. This segment offers high-growth opportunities but requires tailored pricing and distribution strategies.

Long-Term Outlook

While short-term growth may stabilize post-peak adoption, long-term prospects hinge on innovation, regulatory adaptability, and competitive positioning. The increasing shift toward personalized medicine and combination regimens suggests potential for KOMBIGLYZE XR to evolve alongside evolving standards of care.

Key Challenges

• Patent expiration and generic competition
• Pricing pressures amid healthcare cost containment
• Rapid innovation in alternative therapies, including GLP-1 and SGLT2 inhibitors
• Regulatory hurdles in emerging markets
• Patient adherence and real-world efficacy concerns

Opportunities for Growth

• Expansion into prediabetes treatment domains
• Incorporation into combination therapies for broader metabolic syndromes
• Development of new delivery formats to improve compliance
• Clinical trials for additional indications, including cardiovascular and renal benefits
• Strategic alliances for market access and distribution

Conclusion

KOMBIGLYZE XR operates within a dynamic and competitive diabetic therapeutics landscape characterized by steady demand growth, regulatory shifts, and patent cycles. Its future financial trajectory will depend on effective lifecycle management, innovation, and navigating market challenges while leveraging its strengths in adherence and therapeutic efficacy.

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Key Takeaways

• The global diabetes market’s growth underpins the demand for combination therapies like KOMBIGLYZE XR.
• Patent life, regulatory environment, and competitive innovations are critical factors influencing its market longevity.
• Price sensitivity and reimbursement policies significantly shape revenue potential.
• Diversification into new indications and formulations can extend product lifecycle.
• Long-term success depends on strategic positioning amid emerging therapies and market dynamics.

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Frequently Asked Questions

1. What are the primary advantages of KOMBIGLYZE XR over competing therapies?
KOMBIGLYZE XR offers combined DPP-4 inhibition with extended-release metformin, enhancing patient adherence, improving convenience through a fixed-dose formulation, and demonstrating favorable tolerability profiles.

2. How does patent expiration impact KOMBIGLYZE XR’s market prospects?
Patent expiration around late 2020s risks generic entry, which can significantly lower prices and market share. Strategic lifecycle extensions and new indications are necessary to mitigate these effects.

3. What role do healthcare policies play in the adoption of KOMBIGLYZE XR?
Reimbursement and formulary inclusion heavily influence prescribing patterns. Favorable policies improve market penetration, while cost-containment measures can restrict access and sales.

4. How is the emerging landscape of new diabetes treatments affecting KOMBIGLYZE XR?
Innovations such as SGLT2 inhibitors and GLP-1 receptor agonists with cardiovascular benefits challenge the market share of DPP-4 inhibitors, necessitating differentiation and evidence of additional benefits.

5. What market segments offer the most growth potential for KOMBIGLYZE XR?
Emerging markets with increasing diabetes prevalence and patient populations seeking convenient, effective therapies present substantial growth opportunities, provided affordability and infrastructure challenges are addressed.

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References

[1] MarketWatch. (2022). "Global Diabetes Therapeutics Market Size, Share & Trends Analysis."