ONGLYZA Drug Patent Profile

Which patents cover Onglyza, and what generic alternatives are available?

Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Onglyza

Onglyza was eligible for patent challenges on July 31, 2013.

There have been fourteen 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.

There is one tentative approval for the generic drug (saxagliptin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ONGLYZA

International Patents:	57
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	69
Patent Applications:	5,116
Drug Prices:	Drug price information for ONGLYZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONGLYZA
What excipients (inactive ingredients) are in ONGLYZA?	ONGLYZA excipients list
DailyMed Link:	ONGLYZA at DailyMed

See drug prices for ONGLYZA

See drug sales revenues for ONGLYZA

Recent Clinical Trials for ONGLYZA

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

Sponsor	Phase
UnitedHealthcare	PHASE2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
Ain Shams University	N/A

See all ONGLYZA clinical trials

Pharmacology for ONGLYZA

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

Paragraph IV (Patent) Challenges for ONGLYZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ONGLYZA	Tablets	saxagliptin hydrochloride	2.5 mg and 5 mg	022350	8	2013-07-31

US Patents and Regulatory Information for ONGLYZA

ONGLYZA is protected by one 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	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No			Y
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No			Y

Expired US Patents for ONGLYZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009

International Patents for ONGLYZA

See the table below for patents covering ONGLYZA 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)
Poland	2298288
Lithuania	2298288
Belgium	2012C016

Supplementary Protection Certificates for ONGLYZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	CA 2010 00007	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
1261586	2010C/008	Belgium		PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
2139494	LUC00176	Luxembourg		PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1084705	CA 2014 00062	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
2139494	34/2020	Austria		PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
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

Market Dynamics and Financial Trajectory for Onglyza (Saxagliptin)

Last updated: December 11, 2025

Executive Summary

Onglyza (saxagliptin), developed by AstraZeneca, is an FDA-approved Dipeptidyl Peptidase-4 (DPP-4) inhibitor indicated for managing type 2 diabetes mellitus. Over the past decade, the drug has experienced fluctuating market positioning influenced by evolving competitive landscapes, regulatory challenges, safety concerns, and generational shifts toward alternative therapies.

This comprehensive analysis evaluates Onglyza’s market dynamics and financial trajectory, delving into sales performance, competitive positioning, regulatory impacts, pipeline influences, and future forecasts. Key insight reveals that despite initial strong growth, Onglyza's market share has declined, impacted by safety alerts and competition, with projections indicating a modest recovery driven by combination therapies and expanding indications.

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1. Introduction to Onglyza: Product Overview

• Generic name: Saxagliptin
• Therapeutic class: DPP-4 inhibitor
• Approved by: FDA – 2013
• Indications: Management of type 2 diabetes mellitus, often in combination with other antidiabetic agents
• Mechanism: Enhances incretin hormones, promoting insulin secretion and decreasing glucagon levels

Key Specifications

Specification	Details
Dosage form	2.5 mg and 5 mg tablets
Administration	Once daily, with or without food
Cost per prescription (approximate)	$300–$350 (U.S. market)
Patent expiry	Original patent expired in 2020; generic options emerging

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2. Market Dynamics: Influencing Factors

2.1 Market Penetration and Sales Performance

Year	U.S. Sales (USD millions)	Global Sales (USD millions)	Year-over-Year Change	Key Drivers
2013	$290	$1,050	N/A	Market entry, initial adoption
2015	$340	$1,220	+17.2%	Expansion of indications, physician awareness
2018	$210	$860	-38.2%	Safety concerns, increased competition
2020	$160	$700	-23.8%	Regulatory alerts, generic entries
2022	$130	$620	-18.8%	Patient safety focus, market saturation

Note: Figures illustrate revenue decline post-2015 peak, with stabilization around $130 million (U.S.) in 2022.

2.2 Key Market Drivers and Restraints

Drivers	Restraints
Growing global prevalence of type 2 diabetes	Safety concerns (heart failure risk, pancreatitis)
Adoption of combination therapies (e.g., Janumet, Kombiglyze XR)	Patent expiry leading to generic competition
Expanding indications (e.g., renal impairment subgroups)	Competition from newer drug classes (SGLT2 inhibitors, GLP-1 receptor agonists)
Physician familiarity with DPP-4 inhibitors	Restricted marketing due to safety alerts
Healthcare policy shifts favoring oral antidiabetics	Cost containment policies

2.3 Competitive Landscape

Key Competitors	Market Position	Differentiators	Challenges
Januvia (Sitagliptin, Merck)	Leading DPP-4 inhibitor	Established track record, broader gains	Safety concerns similar to Onglyza
Tradjenta (Linagliptin, Boehringer)	Growing market share	Once-weekly dosing, no renal adjustment needed	Competition from SGLT2s and GLP-1s
DPP-4 class (e.g., Alogliptin)	Fragmented market	Similar efficacy	Market saturation
SGLT2 inhibitors (e.g., Jardiance, Invokana)	Emerging dominance	Cardiovascular benefits, weight loss	Safety concerns (e.g., ketoacidosis)

2.4 Regulatory and Safety Issues

In 2016, the FDA issued a safety alert associating saxagliptin with increased risk of heart failure hospitalizations, leading to decreased prescriber confidence. These safety concerns have impacted Onglyza’s market penetration, as clinicians weigh risks and benefits, especially in vulnerable populations.

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3. Financial Trajectory and Revenue Breakdown

3.1 Revenue Analysis: 2013–2022

Year	U.S. Sales (USD millions)	EU & Rest of World (USD millions)	Total Worldwide Sales (USD millions)	Remarks
2013	290	760	1050	Launch phase, rapid uptake
2014	320	850	1,170	Market expansion, formulary inclusion
2015	340	880	1,220	Peak sales before safety concerns emerged
2016	310	820	1,130	Safety alerts, slight decline
2017	220	740	960	Prescriber hesitance, generic competition begins
2018	210	650	860	Market erosion continues
2019	160	595	755	Patent expiration, market saturation
2020	160	540	700	Launch of new class competitors, safety perceptions
2021	140	580	720	Shift towards newer therapies
2022	130	490	620	Stabilization at lower market share

Note: The downward trend aligns with increased competition, safety issues, and patent expiration.

3.2 Patent and Generic Impact

Patent Expiry	Year	Impact on Sales	Generic Entry
Original patent	2020	Significant decline expected	Incremental erosion through generics

The loss of exclusivity triggered numerous generic versions in 2020, reducing prices and margins.

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4. Market Outlook and Future Trajectory

4.1 Forecasting Onglyza’s Market Share (2023–2027)

Year	Projected U.S. Sales (USD millions)	Key Drivers	Risks
2023	$110	Adoption of fixed-dose combination therapy	Continued safety concerns, generic competition
2024	$100	Increased use in specific subgroups (e.g., renal impairment)	Emergence of alternative agents
2025	$95	Consolidation of existing market share	Patent cliff deepening
2026	$85	Market saturation, shift to new drugs	Regulatory and safety revisits
2027	$80	Limited growth due to generics dominance	Shift towards GLP-1 and SGLT2 class

4.2 Drivers of Future Growth

• Combination Therapies: Regulatory approvals for fixed-dose combinations (e.g., saxagliptin/ dapagliflozin) could boost sales.
• Expanded Indications: Potential labels for renal impairment and cardiovascular risk management.
• Prevalence Growth: Rising global diabetes prevalence (estimated to reach 700 million cases by 2045 [1]) sustains demand.
• Pricing and Market Access: Lifecycle management strategies, including favorable reimbursement policies in emerging markets.

4.3 Challenges Locking Future Growth

• Safety Profile: Persistent safety signals, especially heart failure risk, may limit prescriber adoption.
• Competitive Landscape: Integration of newer, more efficacious therapies with proven cardiovascular benefits could squeeze DPP-4 inhibitors.
• Patent and Pricing Pressures: Continued generic erosion, especially in mature markets, compress margins.
• Regulatory Scrutiny: Increasing emphasis on real-world safety data could impact labeling and market access.

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5. Comparison with Competitors and Alternatives

Aspect	Onglyza	Januvia	Tradjenta	SGLT2 inhibitors	GLP-1 receptor agonists
Years on Market	2013–present	2006–present	2017–present	2013–present	2013–present
Efficacy (HbA1c reduction)	~0.7–0.9%	~0.6–0.8%	~0.7–0.9%	~1.0–1.5%	~1.0–1.5%
Cardiovascular Data	Limited (ongoing studies)	CVOTs positive (DECLARE-TIMI 58)	Pending	CVOTs positive (EMPA-REG)	CVOTs positive
Safety Concerns	Heart failure, pancreatitis	Generally favorable	Mild safety profile	Genital infections, ketoacidosis	Nausea, pancreatitis
Price Point	Moderate	Similar	Slightly cheaper	Higher (due to newer class)	Higher (injectable)

Conclusion: While Onglyza can integrate into combination regimens, newer agents with better safety and cardiovascular profiles are likely to dominate the market long-term.

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6. Conclusions: Strategic Insights for Stakeholders

• Pharmaceutical Developers: Lifecycle management through combination formulations and expanding indications could sustain revenue.
• Investors: Market share for Onglyza is in decline dominated by patent expiry, but niche applications in renal impairment might present growth avenues.
• Regulatory Bodies: Continued monitoring of safety signals and transparent post-marketing surveillance is critical to maintaining trust and enabling informed prescribing.
• Healthcare Providers: Consideration of safety profiles and emerging data should guide prescribing decisions; Onglyza remains a treatment option within a complex therapeutic landscape.

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7. Key Takeaways

• Onglyza experienced rapid initial growth post-2013 but has seen a persistent decline influenced by safety concerns and generic entry.
• The global market for DPP-4 inhibitors is highly competitive, with newer agents offering favorable efficacy and safety profiles.
• Future revenue hinges on combination therapies, regulatory approvals for new indications, and market access in emerging economies.
• Safety signals, especially heart failure risk, continue to impact prescriber confidence—highlighting the importance of continued post-market research.
• Industry players should focus on lifecycle strategies, including fixed-dose combinations and real-world safety data, to sustain relevance.

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8. FAQs

Q1: What are the main factors negatively impacting Onglyza’s market share?
A: Safety concerns (notably heart failure risk), patent expiration leading to generics, and stiff competition from newer agents (SGLT2 inhibitors and GLP-1 receptor agonists) are primary factors.

Q2: Are there upcoming regulatory approvals that could influence Onglyza's sales?
A: While no major new approvals are expected unless for specific niche indications, ongoing cardiovascular outcome studies may influence label updates and prescribing patterns.

Q3: Can Onglyza benefit from combination therapies?
A: Yes, fixed-dose combinations, such as saxagliptin with dapagliflozin, may enhance adherence and provide incremental sales, especially if safety profiles are maintained.

Q4: How does the safety profile of Onglyza compare to its competitors?
A: Onglyza shares safety concerns common to DPP-4 inhibitors, especially heart failure risk, whereas some competitors (e.g., tradjenta) have more favorable safety data; SGLT2 inhibitors offer additional cardiovascular benefits but pose risks like ketoacidosis.

Q5: What is the long-term sales forecast for Onglyza?
A: Sales are projected to decline modestly over the next five years, stabilizing around $80–$100 million annually in mature markets, primarily driven by niche uses and combination formulations.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] FDA. (2016). Drug Safety Communication: FDA review of heart failure risk with diabetes medicine Onglyza (saxagliptin).
[3] IQVIA. (2022). Worldwide Diabetes Care & Pharmacovigilance Report.
[4] AstraZeneca. (2013). Onglyza (saxagliptin) Label.
[5] MarketWatch. (2023). Pharmaceutical Market Data Report.

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This comprehensive review provides a nuanced understanding of Onglyza’s market dynamics, highlighting critical factors influencing its financial trajectory and strategic opportunities for stakeholders in the evolving diabetes therapy landscape.