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. Two 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
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
Karolinska Institutet	Phase 3
The First Affiliated Hospital of Guangzhou Medical University	Phase 3

See all KOMBIGLYZE XR clinical trials

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 zero US patents and one FDA Regulatory Exclusivity.

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	200678-003	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010

International Patents for KOMBIGLYZE XR

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

Country	Patent Number	Title	Estimated Expiration
Argentina	027634	INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV, METODO DE TRATAMIENTO Y COMPOSICION FARMACEUTICA.
Austria	396176
Australia	2001245466
Australia	4546601
Belgium	2010C008
Belgium	2012C016
Brazil	0109115	INIBIDORES DE DIPEPTIDIL PEPTIDASE IV À BASE DE PIRROLIDINA DE CICLOPROPIL FUNDIDO E MÉTODO

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1412357	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 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
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716

KOMBIGLYZE XR: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is KOMBIGLYZE XR and where does it sit in the market?

KOMBIGLYZE XR is the brand name for saxagliptin/metformin extended-release (a DPP-4 inhibitor plus metformin ER) indicated for type 2 diabetes. Commercially, it is positioned in the broader “oral diabetes” market where pricing, formulary access, and generic entry determine revenue outcomes.

Core product profile

• Active ingredients: saxagliptin + metformin ER
• Therapy class: DPP-4 inhibitor combination with metformin
• Drug segment: oral anti-diabetic therapy (fixed-dose combination)

How has the competitive landscape shifted around DPP-4 + metformin ER?

KOMBIGLYZE XR’s market dynamics have been dominated by two forces: (1) class-level pressure on DPP-4 utilization following safety-linked scrutiny of saxagliptin and (2) loss of exclusivity and generic substitution for metformin-based and DPP-4-containing products.

Class and payer pressure

• DPP-4 products face continued payer scrutiny and formulary steering versus newer classes that have gained market share, including GLP-1 receptor agonists and SGLT2 inhibitors, which are often preferred on outcomes and payer economics in many formularies.
• Within DPP-4, saxagliptin has experienced utilization headwinds relative to competitors due to safety communications tied to cardiovascular outcomes for the class.

Implication for KOMBIGLYZE XR

Because KOMBIGLYZE XR is a fixed-dose combination, it cannot “switch” with the market. Once payers and prescribers reduce DPP-4 usage and once generic versions expand, the brand has limited ability to defend share purely through marketing or indication expansions.

What happened to sales after generic entry and exclusivity erosion?

KOMBIGLYZE XR’s financial trajectory aligns with typical brand erosion patterns: peak brand monetization followed by volume decline as generics and therapeutic alternatives gain share, with a further hit when rebates intensify to defend formulary position.

Financial trajectory (directional)

• Trend: declining net sales after exclusivity
• Mechanism: generic substitution plus therapeutic substitution

This is consistent with the broader pattern for combination products that combine a DPP-4 component with metformin ER, where:

• DPP-4 patent portfolios expire or face earlier generic challenges, and
• metformin ER has high generic penetration and strong payer favorability.

What do regulatory and labeling facts imply for market access and substitution risk?

KOMBIGLYZE XR’s labeling is stable for its core indication, which means its market position depends less on brand differentiation and more on price and formulary coverage.

Labeling and access

• The drug’s principal value proposition is convenience (fixed-dose combination) and adherence.
• Once lower-cost equivalents exist, that convenience advantage weakens because prescribers and pharmacies can substitute using lower-cost generics.

How does the broader Orals-to-Injectables shift affect KOMBIGLYZE XR economics?

The long-term economics of oral diabetes brands face structural headwinds as GLP-1 and SGLT2 adoption grows. Even when oral therapies remain prescribed, payers increasingly use step edits and preferred tiers that steer patients toward agents with stronger payer-backed adoption.

Market dynamics

• Increased use of GLP-1 and SGLT2 reduces demand elasticity for DPP-4 combinations.
• Oral combination products still compete, but they compete with higher-preference classes and with cheaper generics.

What are the key financial drivers for KOMBIGLYZE XR going forward?

KOMBIGLYZE XR’s future financial performance in a post-exclusivity world depends on four levers.

1) Formulary status and rebate intensity

• Loss of preferred tier placement drives volume erosion.
• Rebates increase to hold onto accounts, compressing net profitability.

2) Generic pricing spread

• Once generic versions control the market, KOMBIGLYZE XR’s price premium becomes hard to sustain.
• The spread between brand and generic prices determines substitution speed.

3) Persistency and patient switching

• Fixed-dose combination convenience supports persistency early, but after generic availability, switching is common.
• Switching accelerates when formularies enforce lower-cost alternatives.

4) Therapeutic substitution

• As prescribers shift patients to GLP-1/SGLT2 regimens, DPP-4 combination demand declines even without brand-generic dynamics.

How does IP and lifecycle timing typically play out for this product class?

Lifecycle dynamics for DPP-4/metformin fixed-dose combinations generally follow a sequence:

1. Brand leadership period: patent-protected premium.
2. Exclusivity loss: generic launches begin.
3. Post-launch erosion: share falls quickly; net sales decline with price pressure and rebates.
4. Stabilization or exit: remaining demand is sustained only at a reduced level.

For KOMBIGLYZE XR, that sequence maps to the observed commercial reality in the US market for similar products, where branded DPP-4 combinations become revenue-light over time after generic entry.

What specific data points tie KOMBIGLYZE XR to saxagliptin safety scrutiny?

Saxagliptin has been subject to safety-related communications tied to cardiovascular outcomes that altered prescribing patterns for the DPP-4 class. That impacts KOMBIGLYZE XR through the saxagliptin component.

• FDA communications in the class have influenced clinicians and payers to reassess saxagliptin use versus alternatives. (See FDA safety communications and class-related updates in referenced materials.) [1][2]

Market trajectory summary: where KOMBIGLYZE XR is in the value chain

KOMBIGLYZE XR sits in a late-cycle position typical for older diabetes brands post-exclusivity:

• Primary competition: generic saxagliptin/metformin ER equivalents and alternative branded therapies (GLP-1 and SGLT2 classes, plus other DPP-4 combinations depending on formulary).
• Main revenue risk: net price compression from generic substitution and formulary tier changes.
• Main share risk: therapeutic substitution away from DPP-4 combinations.

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Key Takeaways

• KOMBIGLYZE XR is a saxagliptin/metformin ER fixed-dose combination whose long-run performance is dominated by generic substitution and therapeutic substitution away from DPP-4-based regimens.
• Its financial trajectory has followed a brand erosion path typical of late-cycle diabetes products: declining volume, net price pressure from rebates and competitive pricing.
• Saxagliptin class-level safety scrutiny has added payer and prescriber friction, strengthening the headwind versus newer, preferred diabetes classes.
• Future performance hinges on formulary positioning, rebate economics, and how quickly patients and prescribers switch to lower-cost generics and higher-preference therapeutic categories.

FAQs

1) Is KOMBIGLYZE XR a DPP-4 inhibitor or metformin product?

It is a fixed-dose combination of saxagliptin (DPP-4 inhibitor) and metformin extended-release.

2) What drives KOMBIGLYZE XR revenue decline post-launch?

The dominant drivers are generic substitution, formulary tier loss, and therapeutic shift toward GLP-1 and SGLT2 agents.

3) Does KOMBIGLYZE XR have meaningful differentiation after generic entry?

Differentiation typically weakens because the market value shifts to price and access, and fixed-dose convenience is easier to replicate with lower-cost alternatives.

4) How does saxagliptin safety communication affect the product?

It contributes to prescribing and payer skepticism toward saxagliptin-containing regimens, which flows through to combinations like KOMBIGLYZE XR.

5) What is the most important lever for near-term market performance?

Formulary status and net pricing/rebate economics determine whether remaining demand is retained at acceptable margins.

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References (APA)

[1] U.S. Food and Drug Administration. (2016). FDA Drug Safety Communication: Ongoing safety review of Onglyza (saxagliptin) and Janumet (sitagliptin and metformin) and related products. https://www.fda.gov/drugs/drug-safety-and-availability
[2] U.S. Food and Drug Administration. (2017). Cardiovascular outcomes trials for DPP-4 inhibitors (labeling updates and related communications). https://www.fda.gov/drugs/drug-safety-and-availability
[3] U.S. Food and Drug Administration. (n.d.). KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm