Saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for saxagliptin hydrochloride and what is the scope of freedom to operate?

Saxagliptin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab, Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.

There are eight drug master file entries for saxagliptin hydrochloride. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for saxagliptin hydrochloride

International Patents:	57
US Patents:	1
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	123
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for saxagliptin hydrochloride
DailyMed Link:	saxagliptin hydrochloride at DailyMed

Recent Clinical Trials for saxagliptin hydrochloride

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

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
UnitedHealthcare	PHASE2
J & A Oben Foundation	PHASE1

See all saxagliptin hydrochloride clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for saxagliptin hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for saxagliptin hydrochloride

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SAXAGLIPTIN HYDROCHLORIDE

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 saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205972-002	Jul 31, 2023	AB	RX	No	No
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No			Y
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No

Expired US Patents for saxagliptin hydrochloride

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 saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Mexico	PA06013711	FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.)
South Korea	20070027560	COATED TABLET FORMULATION AND METHOD
Ukraine	88168	ПРЕПАРАТ В ВИДЕ ТАБЛЕТКИ САКСАГЛИПТИНА С ПОКРЫТИЕМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ;ПРЕПАРАТ У ВИГЛЯДІ ТАБЛЕТКИ САКСАГЛІПТИНУ З ПОКРИТТЯМ І СПОСІБ ЙОГО ВИГОТОВЛЕННЯ (COATED TABLET FORMULATION COMPRISING SAXAGLIPITIN AND METHOD FOR FORMING THEREOF)
New Zealand	551591	Coated tablet formulation and method

Supplementary Protection Certificates for saxagliptin hydrochloride

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
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
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
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

Market Dynamics and Financial Trajectory for Saxagliptin Hydrochloride

Last updated: July 27, 2025

Introduction

Saxagliptin hydrochloride, marketed under the brand name Onglyza™, is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor approved by the FDA in 2009 for managing Type 2 Diabetes Mellitus (T2DM). Its mechanism of enhancing incretin levels offers an oral therapy option that complements other antidiabetic agents. Since its launch, saxagliptin's market presence has evolved amid competitive pressures, regulatory updates, and shifting treatment paradigms. This analysis explores the key market drivers, challenges, and financial outlook shaping saxagliptin hydrochloride's trajectory.

Market Landscape and Demand Drivers

Rising Global Prevalence of Diabetes

The expanding diabetes epidemic remains the primary force propelling saxagliptin’s market. According to the International Diabetes Federation (IDF), approximately 537 million adults had diabetes in 2021, projected to reach 643 million by 2030. T2DM accounts for over 90% of these cases. The growth of this demographic drives demand for effective, convenient oral therapies like saxagliptin.

Therapeutic Positioning and Competitor Dynamics

Saxagliptin positioned as a once-daily oral agent offering moderate glycemic efficacy with a favorable side effect profile. However, intensifying competition from drug classes such as Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors, Glucagon-like Peptide-1 (GLP-1) receptor agonists, and other DPP-4 inhibitors impacts market share. Major competitors include sitagliptin (Januvia), linagliptin (Tradjenta), and alogliptin (Nesina). Differentiation hinges on efficacy, safety, and cardiovascular benefits.

Cardiovascular and Safety Profile Impact

Post-marketing studies, such as the SAVOR-TIMI 53 trial, revealed that saxagliptin was associated with an increased risk of hospitalization for heart failure. Regulatory agencies issued warnings, affecting prescriber confidence and market acceptance. Consequently, cardiology-focused indications for DPP-4 inhibitors have narrowed, especially after competing evidence favored SGLT2 inhibitors and GLP-1 agents with proven cardiovascular benefits.

Regulatory and Reimbursement Environment

Evolving regulatory standards emphasize cardiovascular safety and real-world effectiveness. Payers and healthcare systems increasingly favor high-value therapies, potentially limiting saxagliptin’s reimbursement in some markets. Cost considerations influence prescribing patterns, especially as newer agents demonstrate additional benefits.

Patent Expiry and Generic Entry

Originally protected until 2024, patent expiration for saxagliptin opens avenues for generic competition, likely exerting downward pressure on price points. Patent cliffs typically lead to a sharp decline in branded sales, compelling manufacturers to seek lifecycle management strategies such as formulation enhancements or combination therapies.

Financial Trajectory

Historical Sales Performance

Saxagliptin has experienced modest but steady sales since its launch. In the United States, peak annual sales approached approximately $1.2 billion (2012-2014). Over time, sales plateaued due to market saturation and competitive shifts, with recent figures reflecting a decline toward mid-single-digit millions globally, primarily driven by continued adoption in select regions and off-label use.

Impact of Market Competition and Patent Expiry

The upcoming patent expiry will likely accelerate revenue decline, as biosimilars and generics penetrate key markets. Companies will face the challenge of maintaining profitability, potentially seeking strategic alliances, bundling with combination products, or pivoting toward niche indications such as monotherapy in specific patient subsets.

Pipeline and Lifecycle Management Strategies

Manufacturers are exploring fixed-dose combinations (FDCs) blending saxagliptin with other antidiabetics like metformin or dapagliflozin, enhancing adherence and extending product viability. Additionally, investigating new formulations (e.g., extended-release) or repurposing for other metabolic conditions could mitigate revenue erosion.

Forecasting Future Revenue

Projections suggest that, absent significant lifecycle extensions, saxagliptin’s global sales may decline by approximately 50-70% within five years post-patent expiry. Growth in emerging markets, where diabetes prevalence is rising and generic options are less accessible initially, might temporarily cushion declines.

Strategic Opportunities

Commercial success hinges on differentiation through combination therapies, personalized medicine approaches, and leveraging digital health integrations. Collaborations with diagnostic firms or digital health startups could unlock new formulations or dosing strategies aligned with contemporary treatment paradigms.

Market Challenges Impacting Financial Performance

• Safety Concerns: Regulatory warnings linking saxagliptin to heart failure risk have curtailed its use among high-risk cardiovascular patients.
• Competitive Advantage Loss: The shift favoring agents with proven cardiovascular and renal benefits narrows saxagliptin’s positioning.
• Regulatory Scrutiny: Ongoing safety and efficacy assessments necessitate investments in pharmacovigilance and lifecycle management.
• Pricing Pressures: Payer policies increasingly favor generics and cost-effective agents, compressing margins.

Strategic Outlook and Recommendations

• Focus on Niche Markets: Targeting specific patient populations with contraindications to other therapies or those requiring monotherapy could sustain sales.
• Develop Combination Products: Co-formulations that improve adherence and simplify regimens are critical for retaining market relevance.
• Invest in Real-World Evidence: Demonstrating comparative safety and efficacy may reassure clinicians and regulators amid prevailing safety concerns.
• Explore New Indications: Investigations into saxagliptin’s role in non-diabetic metabolic syndromes may unlock additional revenue streams.
• Lifecycle Management: Pursuing patent extensions, reformulations, or novel delivery mechanisms can extend product life.

Conclusion

Saxagliptin hydrochloride's market outlook is characterized by moderate demand driven by the global diabetes epidemic but tempered by increased competition, regulatory challenges, and impending patent expiration. Its financial trajectory will likely see a decline unless strategic measures—such as combination formulations and niche targeting—are implemented. Navigating this landscape requires proactive lifecycle management and innovation aligned with evolving clinical evidence and market needs.

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Key Takeaways

• The global rise in diabetes prevalence sustains demand for saxagliptin, but competitive pressure from other antidiabetic agents is intense.
• Safety concerns, especially regarding heart failure risk, have influenced regulatory stance and prescriber adoption.
• Patent expiration imminent in key markets will likely lead to a significant revenue decline, unless mitigated by strategic lifecycle management.
• Developing combination therapies and exploring new indications are essential to prolong product viability.
• Market success depends on agility in responding to safety data, regulatory changes, and evolving treatment standards.

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FAQs

1. How does saxagliptin compare to other DPP-4 inhibitors in terms of efficacy?
Saxagliptin demonstrates comparable glycemic efficacy to other DPP-4 inhibitors like sitagliptin and linagliptin. Differences are marginal and primarily hinge on dosing convenience, safety profiles, and cardiovascular outcomes rather than efficacy alone.

2. What are the primary safety concerns associated with saxagliptin?
Post-marketing studies identified an elevated risk of heart failure hospitalization, particularly in patients with existing cardiovascular or renal impairments, leading to regulatory warnings and influencing prescribing practices.

3. How will patent expiration affect saxagliptin's market?
Patent expiry will facilitate generic entry, likely leading to significant price reductions and sales volume declines. Companies are pursuing combination formulations and lifecycle strategies to maintain competitiveness.

4. Are there new therapeutic uses or combinations involving saxagliptin?
Current research focuses mainly on combination therapies with metformin, SGLT2 inhibitors, and other agents, aiming to improve adherence and efficacy. Exploration of non-diabetic indications remains limited.

5. What strategic measures can manufacturers adopt to sustain saxagliptin’s market presence?
Strategies include developing fixed-dose combinations, targeting specific patient populations, investing in real-world data to bolster safety profiles, and exploring new indications or formulations for extended product life.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. US Food and Drug Administration. FDA Drug Approvals and Safety Alerts, 2009–2022.
3. Scirica, B. M., et al. "SAVOR-TIMI 53: Safety and cardiovascular outcomes with saxagliptin." New England Journal of Medicine, 2013.
4. European Medicines Agency. Summary of Product Characteristics for Onglyza™.
5. MarketResearch.com. "Global Diabetic Medications Market Outlook," 2022.