saxagliptin hydrochloride - Profile

What are the generic sources for saxagliptin hydrochloride and what is the scope of patent protection?

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 is one tentative approval for this compound.

Summary for saxagliptin hydrochloride

International Patents:	57
US Patents:	1
Tradenames:	2
Applicants:	6
NDAs:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for saxagliptin hydrochloride

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.

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
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
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-002	Jul 31, 2023		DISCN	No	No
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205972-001	Jul 31, 2023	AB	RX	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
Argentina	049062	FORMULACION DE TABLETA REVESTIDA QUE CONTIENE UN INHIBIDOR DPP4, COMO SAXAGLIPTINA, Y METODO
Argentina	099567	FORMULACIÓN DE TABLETA REVESTIDA QUE COMPRENDE SAXAGLIPTINA Y MÉTODO DE PREPARACIÓN
Australia	2005249467	Coated tablet formulation and method
Brazil	PI0510419	formulação e método de comprimido revestido
Canada	2568391	FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD)

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	202040036	Slovenia		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF NATIONAL AUTHORISATION: 20160715; AUTHORITY FOR NATIONAL AUTHORISATION: EU
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1084705	CR 2014 00062	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1261586	SPC/GB10/001	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001

Saxagliptin Hydrochloride: Investment Scenario and Fundamentals Analysis

Last updated: February 5, 2026

Overview

Saxagliptin hydrochloride is a dipeptidyl peptidase-4 (DPP-4) inhibitor approved for managing type 2 diabetes mellitus (T2DM). Marketed primarily under the brand name Onglyza, it is produced by AstraZeneca. The drug is part of the oral anti-diabetic segment, which has seen steady growth due to rising diabetes prevalence worldwide.

Market Position and Demand Drivers

The global T2DM treatment market exceeds $80 billion in 2022, with DPP-4 inhibitors accounting for approximately 25%-30%. Saxagliptin holds a significant, though declining, market share due to competition from newer agents like SGLT2 inhibitors and GLP-1 receptor agonists. In 2021, AstraZeneca's revenues from Saxagliptin were approximately $900 million, representing sustained demand in established markets.

Demand is driven by:

• Increasing global T2DM prevalence, projected to reach 700 million cases by 2045 (IDF).
• Expansion of treatment guidelines that favor oral agents with good safety profiles.
• Aging populations in North America, Europe, and Asia-Pacific regions.

Market Competition and Patent Landscape

Key competitors include:

• Merck’s Januvia (sitagliptin)
• Novo Nordisk’s Rybelsus (oral semaglutide)
• Eli Lilly’s Trulicity (dulaglutide)
• AstraZeneca’s own formulations in combination therapies

Patents for Saxagliptin expired in most major jurisdictions by 2017, exposing generic competition and compressing margins. As of 2022, patent challenges and biosimilar entries have limited future revenue prospects. AstraZeneca has diversified the franchise through combination products, e.g., Kombiglyze XR (saxagliptin and metformin).

Development and Regulatory Status

Saxagliptin was approved by the FDA in 2009. Post-approval, AstraZeneca pursued label expansions for use in combination therapy and in specific patient populations. No approval extensions or new indications are currently in advanced development stages for Saxagliptin.

Financial Fundamentals

• Revenue trends: Peak revenues reached ~$1.2 billion globally in 2014. Revenues declined gradually post-patent expiry, stabilizing at around $900 million as of 2022.
• Cost structure: Manufacturing costs are moderate, with patent expiration motivating price erosion. R&D expenditures for the franchise declined after initial development but continue to cover lifecycle management.
• Profit margins: Gross margins around 70% before royalties and marketing. Net margin reduced due to increased competition and generic pricing.

Investment Considerations

• Stable cash flow: Mature market presence generates steady revenue, attractive for investment portfolios seeking reliable income streams.
• Competitive pressures: Patent expiry and biosimilar entries threaten long-term revenues.
• Pipeline activity: No significant pipeline developments specific to Saxagliptin; growth prospects depend on franchise expansion, combination therapies, or lifecycle management.
• Regulatory risks: Potential for new safety warnings (e.g., pancreatitis concerns) can impact sales.

Strategic Outlook

Investors should assess AstraZeneca’s broader diabetes portfolio, including newer agents with higher growth potential. Saxagliptin remains a cash-generating asset but faces limited growth opportunities. Portfolio integration and diversification are essential factors for sustained returns.

Key Takeaways

• Saxagliptin is a mature drug with stable but declining revenues.
• Patent expiration has led to increased generic competition reducing margins.
• Market growth in T2DM therapeutics sustains demand, but newer drug classes threaten market share.
• No current pipeline or label expansion plans indicate limited future growth.
• Investment risks include patent cliffs, competitive pressures, and safety concerns.

FAQs

1. What is the main source of revenue for Saxagliptin?
   Sales primarily come from established markets such as North America and Europe, where it is prescribed for T2DM management.

2. How significant is generic competition?
   Very significant; patent expiry in major jurisdictions in 2017 led to price erosion and increased generic penetration.

3. Are there any new formulations or indications?
   No, AstraZeneca has not announced new indications or formulations for Saxagliptin recently.

4. What are the primary risks for investors?
   Patent expiry, biosimilar competition, safety concerns, and limited pipeline development pose risks.

5. Does the market favor Saxagliptin over newer agents?
   No; newer agents such as SGLT2 inhibitors and GLP-1 receptor agonists are gaining market share due to improved efficacy and safety profiles.

Sources

[1] IQVIA, 2022. Global diabetes therapeutics market data.
[2] AstraZeneca Annual Reports, 2014-2022.
[3] International Diabetes Federation, 2022 report.
[4] U.S. Food and Drug Administration, Saxagliptin approval documentation, 2009.