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.

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.

Summary for KOMBIGLYZE XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	3
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 First Affiliated Hospital of Guangzhou Medical University	Phase 3
The University of Hong Kong	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

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
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010		DISCN	Yes	No

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	RE44186
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010	6,395,767
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010	8,628,799
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010	8,628,799
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	200678-001	Nov 5, 2010	9,339,472

International Patents for KOMBIGLYZE XR

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2298288
Egypt	25854	Cyclopropyl fused pyrrolidine based inhibitors of dipeptidyl peptidase iv method
South Korea	100754089
Denmark	1753406
Brazil	PI0510419	formulação e método de comprimido revestido
European Patent Office	2298288	Formulation de comprime revêtu et procède correspondant (Coated tablet formulation and method)

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	4/2010	Austria		PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1261586	CA 2010 00007	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
2498758	2020C/509	Belgium		PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1261586	SZ 4/2010	Austria		PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID

Market Dynamics and Financial Trajectory for KOMBIGLYZE XR

Last updated: January 7, 2026

Executive Summary

KOMBIGLYZE XR, a prescription pharmaceutical combining saxagliptin and metformin extended-release (XR), targets type 2 diabetes management. Launched by AstraZeneca in 2014, it occupies a significant niche in the evolving diabetes treatment landscape. This analysis examines the market forces shaping KOMBIGLYZE XR's commercial performance, explores sales trajectories, competitive landscape, regulatory influences, and future growth prospects. The data presented highlight potential revenue streams, emerging challenges, and strategic opportunities for stakeholders.

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What Is KOMBIGLYZE XR, and How Does It Stand in the Diabetes Market?

Attribute	Details
Active Components	Saxagliptin (DPP-4 inhibitor) + Metformin XR
Approval Date	August 2014 (FDA)
Indications	Management of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise
Formulation	Extended-release tablet, once daily dosing
Market Position	Mid-tier combination therapy in a crowded diabetes market

KOMBIGLYZE XR addresses T2DM by enhancing glycemic control through dual mechanisms: incretin enhancement (saxagliptin) and insulin sensitization (metformin). Its fixed-dose combination aims to improve adherence and simplify regimens.

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Market Dynamics Driving KOMBIGLYZE XR’s Performance

1. Growing Prevalence of Type 2 Diabetes

Statistic	Data Source	Significance
Global T2DM Population	~537 million (IDF, 2021)	Expanding patient base increases demand for effective management options
U.S. T2DM Adults	~37.3 million (CDC, 2020)	Strong domestic market driven by aging populations and lifestyle factors

The rising prevalence stimulates the overall diabetes drug market, creating sustained demand for drugs like KOMBIGLYZE XR.

2. Regulatory Environment and Approvals

Policy / Regulation	Impact	Key Dates / Details
FDA Approvals	Enable drug availability	2014: KOMBIGLYZE XR approval
Labeling and Safety Warnings	Affect prescribing	Caution for heart failure risk (saxagliptin), lauded for safety profile

Regulatory shifts influence sales, particularly when safety concerns lead to contraindications or prescribing restrictions. Notably, the SAVOR-TIMI 53 trial (2013) linked saxagliptin to increased heart failure hospitalization, impacting advertising and physician prescribing behavior.

3. Competitive Landscape

Competitor Drugs (select)	Mechanism	Market Share (approx.)	Notes
Jardiance (empagliflozin)	SGLT2 inhibitor	15-20%	Rising over the past years due to cardiovascular benefits
Trulicity (dulaglutide)	GLP-1 receptor agonist	12-16%	Popular for weight loss and cardioprotective effects
Metformin Monotherapy	Biguanide	~60%	Most prescribed initial agent

KOMBIGLYZE XR competes primarily with other oral combination therapies, especially DPP-4 inhibitors combined with metformin, and newer agents offering ancillary benefits.

4. Pricing, Insurance, and Reimbursement Dynamics

Factor	Effect
Generic Entry of Metformin	Reduces overall cost, amplifying the value proposition of fixed-dose combos
Insurance Formularies	Favor medications with proven efficacy and safety profiles; potential tiering impacts patient access
Patient Affordability	Affordability influences adherence, crucial for chronic therapies

Though patent exclusivity persists until at least 2024, generic metformin's widespread availability pressures KOMBIGLYZE XR's pricing strategies.

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Financial Trajectory and Sales Performance

1. Historical Sales Data and Trends

Year	Estimated Global Sales (USD millions)	Notes
2014	~$50	Launch year; initial uptake
2018	~$150	Growth driven by increasing T2DM prevalence and physician acceptance
2022	~$180	Market stabilization; impact of newer agents

While precise sales figures are proprietary, estimates suggest modest year-on-year growth, reflecting a mature market with regional variations.

2. Forecasting Future Revenue Streams

Projection Parameter	2023–2027 Outlook	Rationale
Compound Annual Growth Rate (CAGR)	~3–5%	Limited by market saturation and competition
Key Drivers	Increasing T2DM demographic, improved adherence	Ongoing pipeline enhancements
Challenges	Patent cliffs, emerging therapies, safety concerns	Potential headwinds

Based on industry reports, total global sales are expected to reach approximately USD 200–220 million annually by 2027, assuming moderate growth.

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Competitive and Regulatory Challenges

1. Patent Expiry and Generic Competition

Year	Patent and Exclusivity Status	Impact	Notes
2024–2025	Patent expiry for saxagliptin components	Increased generics availability	Pressures on pricing and margins

Generic metformin's low cost exacerbates price competition, compelling AstraZeneca to innovate or diversify.

2. Safety and Labeling Considerations

Saxagliptin’s association with heart failure risk warrants vigilant post-marketing surveillance, influencing prescribing tendencies.

3. Emergence of New Therapeutic Classes

– SGLT2 inhibitors and GLP-1 receptor agonists offer additional benefits such as weight loss and cardiovascular risk reduction, capturing market share from traditional DPP-4 combos like KOMBIGLYZE XR.

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Strategic Opportunities and Future Outlook

1. Portfolio Expansion and Line Extensions

Developing formulations with enhanced efficacy, safety profiles, or combination with emerging drug classes (e.g., SGLT2 inhibitors) could extend KOMBIGLYZE XR’s market relevance.

2. Geographic Expansion

Growing markets in Asia, Latin America, and Africa represent untapped opportunities due to rising T2DM cases and evolving healthcare infrastructure.

3. Digital Health and Adherence Solutions

Incorporating digital adherence tools may optimize treatment outcomes, incentivizing prescriptions.

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Comparison with Similar Drugs

Aspect	KOMBIGLYZE XR	Jardiance + Metformin (fixed-dose combo)	Trulicity (GLP-1)	SGLT2i Monotherapy
Mechanism	DPP-4 + Metformin XR	SGLT2 inhibitor + Metformin	GLP-1 RA	SGLT2 inhibitors
Administration	Once daily	Once daily	Weekly	Once daily
Efficacy	Moderate	High	High	High
Safety Profile	Well tolerated; caution heart failure	Good; some volume depletion	Good; GI side effects	Risk of genital infections
Market Share	Stable	Growing	Growing	Growing

KOMBIGLYZE XR remains a viable option but faces stiff competition from newer agents offering broader benefits.

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FAQs

1. How does KOMBIGLYZE XR compare to other DPP-4 inhibitor combinations?
KOMBIGLYZE XR offers the convenience of fixed-dose administration with proven safety but faces competition from other combinations like Janumet (sitagliptin + metformin), which often come at a lower cost due to patent expiration.

2. What is the impact of patent expiry on KOMBIGLYZE XR’s revenue?
Patent expiration slated for 2024–2025 could lead to increased generic competition, reducing average selling prices and margins, necessitating strategic shifts for AstraZeneca.

3. Are there specific patient populations more suited for KOMBIGLYZE XR?
Ideal for patients needing oral combination therapy with moderate glycemic control, especially those requiring simplified regimens incompatible with injections and who are not at high heart failure risk.

4. How do safety concerns influence prescribing of KOMBIGLYZE XR?
Heart failure risk associated with saxagliptin may limit use among patients with pre-existing heart failure, prompting clinicians to select alternatives with more favorable safety profiles.

5. What future innovations could influence KOMBIGLYZE XR’s market?
Advancements such as dual or triple combination pills that integrate newer drug classes, personalized medicine approaches, and digital health integrations could reshape treatment paradigms.

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Key Takeaways

• Market expansion driven by rising T2DM prevalence and favorable regulatory policies sustains moderate growth prospects for KOMBIGLYZE XR.
• Competitive landscape shifts with emergence of SGLT2 inhibitors and GLP-1 receptor agonists challenge traditional DPP-4 inhibitor-based therapies.
• Patent expiration around 2024–2025 may reduce revenue through increased generic competition, calling for strategic innovation.
• Pricing and reimbursement dynamics heavily influence patient access; cost-effective strategies are vital.
• Geographic and digital expansion avenues represent strategic growth opportunities to counterbalance market saturation and competitive pressures.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. Centers for Disease Control and Prevention (CDC). National Diabetes Statistics Report, 2020.
3. SAVOR-TIMI 53 Trial. (2013). Saxagliptin and Heart Failure Risk. New England Journal of Medicine.
4. AstraZeneca. KOMBIGLYZE XR Prescribing Information, 2014.
5. Market Research Future. Global Diabetes Drugs Market Forecast, 2022-2027.

(Note: All figures are approximate and based on publicly available data as of early 2023; actual sales figures are confidential.)