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^® Litigation and Generic Entry Outlook for Kombiglyze Xr

A generic version of KOMBIGLYZE XR was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9^th, 2023.

Summary for KOMBIGLYZE XR

International Patents:	57
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	54
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			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010		DISCN	Yes	No			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
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	200678-001	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	200678-002	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	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
Japan	4460205
Japan	5951843
Taiwan	I415635
Colombia	5280198	INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y METODO
Hong Kong	1049330
Hong Kong	1155399	加衣錠片調製物及製備彼之方法 (COATED TABLET FORMULATION AND METHOD)

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586	SPC005/2010	Ireland		SPC005/2010: 20100702, EXPIRES: 20240930
2498758	LUC00152	Luxembourg		PRODUCT NAME: 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
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
1506211	300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2498758	CR 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

KOMBIGLYZE XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KOMBIGLYZE XR

Introduction

KOMBIGLYZE XR, a combination drug containing saxagliptin and metformin hydrochloride, is a significant player in the treatment of type 2 diabetes mellitus. This article delves into the market dynamics and financial trajectory of KOMBIGLYZE XR, highlighting its clinical significance, market performance, and financial impact on its manufacturers.

Clinical Significance of KOMBIGLYZE XR

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug combines saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with metformin, a biguanide, in an extended-release formulation. This combination provides a comprehensive approach to managing blood sugar levels, making it a valuable treatment option for patients with type 2 diabetes[4].

Market Position and Competition

KOMBIGLYZE XR operates in a competitive market dominated by various antidiabetic medications. However, its unique combination and extended-release formulation set it apart. The drug has been part of a broader diabetes management portfolio for its manufacturers, AstraZeneca and Bristol Myers Squibb.

Partnership and Collaboration

The development and marketing of KOMBIGLYZE XR have been facilitated through a partnership between AstraZeneca and Bristol Myers Squibb. This collaboration has been instrumental in expanding the diabetes treatment offerings of both companies. For instance, Bristol Myers Squibb's 2012 annual report highlighted the significant growth of the Onglyza franchise, which includes KOMBIGLYZE XR, following the acquisition of Amylin Pharmaceuticals and the expansion of their diabetes partnership with AstraZeneca[3].

Regulatory Approvals and Safety Profile

FDA Advisory Committee Review

The FDA Advisory Committee has reviewed the SAVOR outcomes study results for ONGLYZA (saxagliptin), a component of KOMBIGLYZE XR. The study demonstrated that saxagliptin did not increase the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke when added to a patient’s current standard of care. This positive safety profile has been crucial in supporting the supplemental New Drug Applications (sNDAs) for ONGLYZA and KOMBIGLYZE XR[1].

Dosage and Administration

KOMBIGLYZE XR is available in various strengths and is administered once daily with the evening meal. The recommended starting dose and gradual dose titration are designed to reduce gastrointestinal side effects associated with metformin. The drug is contraindicated in patients with severe renal impairment, and its use requires careful monitoring of renal function[4].

Financial Performance

Revenue Growth

KOMBIGLYZE XR has contributed to the revenue growth of its manufacturers. In 2012, Bristol Myers Squibb reported a 50% increase in year-over-year sales of the Onglyza franchise, which includes KOMBIGLYZE XR. This growth was part of a broader trend of increased sales for new and in-line products, driven by the company's BioPharma Transformation initiative[3].

Recent Financial Trends

AstraZeneca's financial reports indicate continued growth in product sales, which includes revenues from KOMBIGLYZE XR. For instance, in Q1 2024, AstraZeneca reported a 19% increase in total revenue, driven by an 18% increase in product sales. While the specific revenue figures for KOMBIGLYZE XR are not detailed, the overall growth in product sales suggests a positive financial trajectory for the drug[2].

Market Dynamics and Trends

Increasing Demand for Antidiabetic Medications

The global demand for antidiabetic medications is on the rise due to the increasing prevalence of type 2 diabetes. This trend is driven by factors such as lifestyle changes, aging populations, and growing awareness of diabetes management. KOMBIGLYZE XR benefits from this increasing demand, positioning it as a significant player in the market.

Competitive Landscape

The antidiabetic market is highly competitive, with various classes of medications available. However, KOMBIGLYZE XR's unique combination and extended-release formulation provide it with a competitive edge. The drug's safety profile, as demonstrated by the SAVOR study, further enhances its market position.

Regulatory and Market Access

Regulatory approvals and market access are critical for the success of any pharmaceutical product. KOMBIGLYZE XR has received approvals in several regions, including Europe and the United States. The drug's inclusion in various formularies and reimbursement lists also supports its market access and adoption by healthcare providers.

Challenges and Opportunities

Renal Impairment Considerations

One of the challenges associated with KOMBIGLYZE XR is its contraindication in patients with severe renal impairment. This limitation requires careful patient selection and monitoring, which can impact its market penetration. However, this also presents an opportunity for targeted marketing and education campaigns to ensure appropriate use.

Emerging Markets

Emerging markets offer significant growth opportunities for KOMBIGLYZE XR. AstraZeneca's financial reports highlight double-digit growth in these regions, driven by increasing healthcare spending and growing awareness of diabetes management. Expanding market access and partnerships in these regions can further boost the drug's revenue.

Financial Projections and Outlook

Revenue Expectations

AstraZeneca's financial projections indicate continued growth in product sales, which is expected to drive revenue increases. While the specific projections for KOMBIGLYZE XR are not detailed, the overall positive outlook for the company's product sales suggests a favorable financial trajectory for the drug.

Investment in R&D and Marketing

Both AstraZeneca and Bristol Myers Squibb have committed to significant investments in research and development (R&D) and marketing. These investments are expected to support the continued growth of KOMBIGLYZE XR by expanding its clinical indications, improving patient outcomes, and enhancing market penetration.

Key Takeaways

• Clinical Significance: KOMBIGLYZE XR is a valuable treatment option for type 2 diabetes, combining saxagliptin and metformin in an extended-release formulation.
• Market Position: The drug operates in a competitive market but benefits from its unique combination and safety profile.
• Financial Performance: KOMBIGLYZE XR has contributed to the revenue growth of its manufacturers, with continued growth expected in product sales.
• Market Dynamics: Increasing demand for antidiabetic medications and strategic market access initiatives support the drug's market position.
• Challenges and Opportunities: Careful patient selection and monitoring due to renal impairment considerations, and growth opportunities in emerging markets.

FAQs

Q: What is KOMBIGLYZE XR used for?

KOMBIGLYZE XR is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Q: What are the components of KOMBIGLYZE XR?

KOMBIGLYZE XR contains saxagliptin, a DPP-4 inhibitor, and metformin hydrochloride, a biguanide, in an extended-release formulation.

Q: What are the key findings of the SAVOR study related to KOMBIGLYZE XR?

The SAVOR study demonstrated that saxagliptin, a component of KOMBIGLYZE XR, did not increase the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke when added to a patient’s current standard of care.

Q: How is KOMBIGLYZE XR administered?

KOMBIGLYZE XR is administered once daily with the evening meal, with gradual dose titration recommended to reduce gastrointestinal side effects associated with metformin.

Q: What are the contraindications for KOMBIGLYZE XR?

KOMBIGLYZE XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m² due to severe renal impairment.