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. Four 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:	4
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
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-002	Jul 31, 2023	AB	RX	No	No
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No	7,951,400		Y
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-002	Jul 31, 2023	AB	RX	No	Yes
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-002	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	6,395,767
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	RE44186
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	RE44186
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	6,395,767

International Patents for saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	101290925
Lithuania	2298288
Denmark	2298288
Hungary	E029446
Hong Kong	1094951	包衣片製劑和方法 (COATED TABLET FORMULATION AND METHOD)

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	301040	Netherlands		PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
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	132020000000115	Italy		PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
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
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

Market Overview and Financial Trajectory of Saxagliptin Hydrochloride

Last updated: February 12, 2026

Saxagliptin hydrochloride is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for managing type 2 diabetes mellitus. It is marketed under the brand name Onglyza by Bristol-Myers Squibb (BMS) and AstraZeneca. The drug's market performance is driven by its efficacy, safety profile, regulatory status, and competitive positioning within the antidiabetic class.

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Market Size and Share

In 2022, the global DPP-4 inhibitor market was valued at approximately $12 billion and is projected to reach around $16 billion by 2027, with a compound annual growth rate (CAGR) of 6.3%. Saxagliptin, as one of the leading drugs in this class, accounts for roughly 25-30% of the DPP-4 segment, driven by its early market entry and clinical positioning.

Sales Performance and Revenue Trends

Bristol-Myers Squibb reported that Saxagliptin generated global sales of approximately $1.2 billion in 2022. The revenue declined from a peak of $1.5 billion in 2019, attributed to the increasing generic competition and market shifts toward SGLT2 inhibitors and GLP-1 receptor agonists.

Key factors impacting sales:

• Patent expiration: The original cardio-metabolic patent expired in 2020 in major markets like the US and Europe, allowing generics to enter.
• Generic competition: Several companies launched generic versions post-2020, significantly affecting Saxagliptin’s market share.
• Brand strategy shifts: BMS and AstraZeneca have pivoted toward combination therapies and new indications, attempting to sustain revenue.

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Regulatory and Patent Landscape

Patent Status:

• Patents related to Saxagliptin expired or are set to expire in key markets between 2020 and 2023.
• Patent expiration enabled multiple generics to market, influencing pricing and sales volume.

Regulatory Approvals:

• Approved in the US (FDA, 2009) and EU (EMA, 2010) for type 2 diabetes.
• Post-market studies showed no major safety concerns, maintaining regulatory approval status.

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Market Dynamics and Competition

Within the DPP-4 class:

• Other drugs like sitagliptin (Januvia), linagliptin (Tradjenta), and alogliptin (Nesina) hold substantial market share.
• Saxagliptin's market share has diminished from approximately 20-25% pre-patent expiry to an estimated 10-15% in 2022.

Emerging competition:

• The rise of SGLT2 inhibitors (empagliflozin, dapagliflozin) and GLP-1 receptor agonists (liraglutide, semaglutide) has led to shifts in prescriber preferences, impacting Saxagliptin's sales trajectory.

Pricing dynamics:

• Post-patent expiry, generic versions price approximately 60-70% lower than branded Saxagliptin.
• Price reductions have pressured margins but expanded access due to affordability.

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Future Growth Drivers

• Combination therapies: Licenses for fixed-dose combinations with metformin and other agents may rekindle demand.
• New indications: Exploration for cardiovascular risk reduction or weight management may create additional markets.
• Pipeline developments: BMS and AstraZeneca are developing next-generation DPP-4 inhibitors with improved profiles; however, these are several years from market entry.

Financial Outlook

Revenue projections:

• The decline in brand sales is unlikely to fully reverse unless new formulations or indications are approved.
• The global market for Saxagliptin is expected to decline at a CAGR of 4-5% over the next five years due to patent losses and competition.

Profitability considerations:

• Generic entry will continue to exert downward pressure on gross margins.
• Continued investment in combination therapies and novel compounds may mitigate revenue decline long-term.

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Key Takeaways

• Saxagliptin hydrochloride margins are contracting due to patent expirations and increasing generics.
• The drug remains relevant through combination products and new indications.
• Competition from SGLT2 inhibitors and GLP-1 receptor agonists is reshaping the type 2 diabetes market.
• Future revenue will depend on pipeline progress, regulatory approvals, and market positioning strategies.

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Frequently Asked Questions

1. How has patent expiry impacted saxagliptin sales?
Patent expiry in 2020 in major markets led to the entry of multiple generic competitors, reducing brand sales by approximately 20-30% within two years.

2. What are the main competitors to saxagliptin?
Sitagliptin, linagliptin, and alogliptin are established competitors within the DPP-4 class. SGLT2 inhibitors and GLP-1 receptor agonists are capturing larger market shares outside the class.

3. Are there emerging indications that could revive saxagliptin’s market?
Research into cardiovascular and weight management benefits could expand indications, but regulatory approval timelines extend several years.

4. What is the outlook for saxagliptin revenue over the next five years?
Revenue is expected to decline at a CAGR of 4-5%, with potential stabilization if new combinations and indications gain approval.

5. How does the pricing of generics affect the market?
Generic versions price approximately 60-70% lower than branded Saxagliptin, significantly decreasing revenue and profit margins for the original manufacturer.

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References

[1] Market research reports on the global DPP-4 inhibitor market (2022).
[2] Bristol-Myers Squibb financial statements (2022).
[3] FDA and EMA approval databases.
[4] Patent expiration timelines for Saxagliptin (2020-2023).