KOMBIGLYZE XR Drug Patent Profile

Which patents cover Kombiglyze Xr, and when can generic versions of Kombiglyze Xr launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KOMBIGLYZE XR

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

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
2498758	CA 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
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
2498758	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1261586	SZ 4/2010	Austria		PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116

KOMBIGLYZE XR Investment and Fundamentals Analysis

Last updated: February 10, 2026

KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) is an oral antihyperglycemic agent approved for type 2 diabetes management. It combines a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin, targeting a common disease with substantial global market potential.

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Market Overview and Growth Drivers

The global type 2 diabetes market reached approximately $115 billion in 2022, with an expected CAGR of around 6% until 2030 ([1]). The rise in prevalence, driven by obesity and aging populations, sustains demand for combination therapies like KOMBIGLYZE XR.

Key growth drivers include:

• Increasing number of diabetic patients worldwide, estimated at 537 million in 2021, projected to reach 643 million by 2030 ([2]).
• Adoption of combination therapies to improve glycemic control and reduce hypoglycemia risks.
• Patent expiration timeframe, which influences generic competition and pricing.

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Regulatory Status and Patent Landscape

KOMBIGLYZE XR holds FDA approval since September 2014 for adults with type 2 diabetes mellitus. Its patent protections expire in the US in 2027 ([3]), creating a runway for exclusivity but upcoming generic entrants could pressure market share.

Emerging biosimilars or generic formulations could enter by 2027, influencing pricing and profitability.

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Financials and Commercial Performance

Sanofi and AstraZeneca market KOMBIGLYZE XR through a distributed network. Specific sales figures are not publicly disclosed but are integrated into broader diabetes franchise revenues. In 2021, Sanofi's diabetes division generated over €4.6 billion, with KOMBIGLYZE XR contributing a segment of this total.

Sales growth has stabilized, attributable to increased competition from alternatives like GLP-1 receptor agonists and SGLT2 inhibitors, which have gained market share for their cardiovascular and weight loss benefits.

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Competitive Landscape

Major competitors include:

• Novo Nordisk's Ozempic and Rybelsus (GLP-1 receptor agonists)
• Eli Lilly's Trulicity
• AstraZeneca's Farxiga

While KOMBIGLYZE XR offers daily oral dosing, these competitors promote additional benefits like weight reduction and cardioprotection.

Market share in the oral antihyperglycemics segment is declining for DPP-4 inhibitors amid these newer options, but KOMBIGLYZE XR maintains niche appeal due to its proven efficacy in glycemic control.

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R&D and Pipeline Status

KOMBIGLYZE XR has limited pipeline expansion under its current formulation. Ongoing research focuses on improving its safety profile and combination with other antidiabetics, but no significant new formulations are announced.

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Pricing and Reimbursement

KOMBIGLYZE XR's list price varies across regions; in the US, a typical 30-day supply costs around $600–$700. Reimbursement depends on insurance coverage, with payers increasingly favoring drugs with proven cardiovascular benefits for type 2 diabetes.

Price erosion is imminent as generics arrive, with generic versions possibly reducing costs by 70–80%.

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Risks and Opportunities

Risks:

• Patent expiration in 2027 increases the risk of generic entry.
• Competition from GLP-1 and SGLT2 inhibitors, which offer additional benefits.
• The evolving standard of care may diminish reliance on DPP-4 inhibitors.

Opportunities:

• Potential expansion into monotherapy or fixed-dose combinations.
• Use in patients intolerant to injectable treatments.
• Growth in markets with expanding healthcare infrastructure.

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Financial Outlook and Investment Implications

Investors should consider:

• Near-term revenue stability until patent expiry in 2027.
• Long-term decline risk post-generic entry unless new indications or formulations are developed.
• The shifting competitive landscape favoring newer drug classes with broader benefits.

Sanofi and AstraZeneca's strategic focus on novel therapies may divert resources from KOMBIGLYZE XR development, impacting future growth prospects.

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Key Takeaways

• KOMBIGLYZE XR addresses an evolving market with steady demand but faces imminent patent expiration in 2027.
• Competition from newer drug classes reduces its market share and pricing power.
• Future growth hinges on pipeline innovations, expanded indications, and market penetration in emerging markets.
• Investors should weigh the potential revenue decline post-2027 versus current cash flows.
• Monitoring regulatory developments and competition will be crucial to assess long-term viability.

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FAQs

1. When does KOMBIGLYZE XR’s patent protection expire?
Patent protection is set to expire in 2027 in the US, opening the market to generic competition.

2. What factors are driving current sales?
Sales are driven by the drug's efficacy in glycemic control, convenience of oral dosing, and established safety profile, though growth is moderated by competition from GLP-1 and SGLT2 inhibitors.

3. How does KOMBIGLYZE XR compare with newer antidiabetic therapies?
It primarily offers glycemic control without added cardiovascular or weight-loss benefits that newer agents provide, reducing its market appeal over time.

4. What is the impact of upcoming generics?
Generic entry around 2027 is expected to significantly reduce price and market share unless new formulations or indications are introduced.

5. Are there any pipeline products to extend KOMBIGLYZE XR’s franchise life?
Current focus is limited; no significant pipeline expansion is publicly disclosed, emphasizing reliance on existing formulations and indications.

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References

[1] MarketsandMarkets. "Diabetes Therapeutics Market." 2022.
[2] International Diabetes Federation. "IDF Diabetes Atlas, 9th Edition." 2021.
[3] FDA Patent and Exclusivity Data. 2023.