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. Six 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:	6
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	121
Patent Applications:	5
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
University of Erlangen-Nürnberg Medical School	Phase 4
Ain Shams University	N/A
Sabyasachi Sen	Phase 3

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
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
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No			Y
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-001	Jul 31, 2023	AB	RX	No	No
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-002	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
Cyprus	1118162
Slovenia	2298288
Serbia	55174	FORMULACIJA I METOD OBLOŽENE TABLETE (COATED TABLET FORMULATION AND METHOD)
Slovenia	1753406
Cyprus	1117813
Israel	218117	טבליה המכילה סאקסאגליפטין ומספר שכבות ציפוי (Tablet comprising saxagliptin and multiple coating layers)

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1084705	SPC/GB14/085	United Kingdom		PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
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	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
2498758	2020C/509	Belgium		PRODUCT NAME: QTRILMET - 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

Saxagliptin hydrochloride Market Analysis and Financial Projection Experimental

Saxagliptin Hydrochloride: Market Dynamics and Financial Trajectory

Market Overview

Saxagliptin hydrochloride, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is a crucial medication in the management of type 2 diabetes mellitus (T2DM). Here’s a detailed look at the market dynamics and financial trajectory of saxagliptin.

Market Size and Growth

The saxagliptin market is projected to grow significantly over the forecast period. By 2027, the market size is estimated to reach $255 million, growing at a Compound Annual Growth Rate (CAGR) of 4.17% from 2022 to 2027[1].

Key Drivers

Increasing Prevalence of Diabetes

The rising global prevalence of type 2 diabetes is a primary driver for the saxagliptin market. With over 420 million people worldwide suffering from diabetes, according to the World Health Organization, the demand for effective diabetes treatments is escalating[3].

Clinical Efficacy

Saxagliptin's proven clinical efficacy in managing blood sugar levels and its role in preventing severe diabetes complications such as kidney damage and blindness contribute to its market growth[1][4].

Government Financing and Healthcare Infrastructure

Increased government financing for healthcare and the expansion of healthcare infrastructure, particularly in regions like North America and the Asia-Pacific, are also driving the market[1][4].

Market Segmentation

By Dosage

The saxagliptin market is segmented by dosage, with the 5 mg segment expected to grow at the fastest CAGR of 4.8% during the forecast period 2022-2027. This is due to the heightened application of Onglyza 5 mg film-coated tablets[1].

By Age Group

The market is also segmented by age group, with adults and geriatrics being the primary segments. The geriatric population, particularly in North America, is a significant contributor due to the increasing prevalence of diabetes among the elderly[1].

By Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. Online pharmacies held the largest market share in 2021, driven by the convenience and ease of use during the COVID-19 pandemic. However, hospital pharmacies are expected to grow with the fastest CAGR of 4.9% as life returns to pre-pandemic normalcy[1].

By Geography

Geographically, North America dominated the market in 2021 and is expected to continue its dominance. The Asia-Pacific region, however, is projected to have the fastest CAGR due to the growing population and increasing healthcare spending in countries like India and China[1][4].

Financial Trajectory

Revenue Forecast

The saxagliptin market is expected to generate significant revenue, with the global market size projected to reach $255 million by 2027. This growth is supported by the increasing adoption of saxagliptin in various regions and the expanding use of DPP-4 inhibitors in diabetes management[1].

Cost-Effectiveness

Studies have shown that saxagliptin, when combined with metformin, is a cost-effective treatment alternative compared to other second-line therapies. For instance, in China, saxagliptin+metformin (SAXA+MET) was found to have lower costs and higher quality-adjusted life-years (QALYs) compared to acarbose+metformin (ACAR+MET)[5].

Competitive Landscape

The saxagliptin market features prominent pharmaceutical companies such as Bristol-Myers Squibb Company, AstraZeneca Plc, and Dr. Reddy’s Laboratories Limited. These companies are engaged in product launches, mergers and acquisitions, and geographical expansions to maintain their market position[1][4].

Market Restraints

Side Effects and Safety Concerns

Despite its efficacy, saxagliptin is associated with side effects such as pancreatitis, heart failure, and hypersensitivity reactions, which can hamper market growth. These safety concerns necessitate careful patient monitoring and management[1].

Regulatory Compliance

Stringent regulatory requirements for pharmaceuticals also pose a challenge. Ensuring compliance with these regulations is crucial for maintaining market presence and expanding product offerings[4].

Market Opportunities

Emerging Markets

Regions with a growing diabetes burden, such as the Asia-Pacific and Latin America, offer significant opportunities for market expansion. Increasing healthcare access and spending in these regions are expected to drive the adoption of saxagliptin[4].

Combination Therapies

The development of combination therapies involving saxagliptin, such as the launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets by Dr. Reddy’s Laboratories Ltd., is expected to enhance market growth. These combination therapies offer improved diabetes management and cost-effective treatment options[3].

Regional Analysis

North America

North America, particularly the United States and Canada, has a significant presence in the saxagliptin market due to the high prevalence of type 2 diabetes and the demand for advanced therapeutic options[1][4].

Europe

Europe, with its aging population and increasing diabetes incidence, also contributes substantially to the market. Countries like Germany and the United Kingdom are key players in this region[4].

Asia-Pacific

The Asia-Pacific region, driven by countries like India and China, is experiencing rapid growth due to increasing diabetes cases and improving healthcare access. This region is expected to have the fastest CAGR over the forecast period[1][4].

Key Takeaways

• Market Growth: The saxagliptin market is expected to reach $255 million by 2027, growing at a CAGR of 4.17% from 2022 to 2027.
• Clinical Efficacy: Saxagliptin's proven clinical efficacy in managing blood sugar levels is a key driver.
• Distribution Channels: Online pharmacies currently dominate, but hospital pharmacies are expected to grow rapidly.
• Geographical Dominance: North America leads the market, but the Asia-Pacific region is growing fastest.
• Cost-Effectiveness: Saxagliptin+metformin is a cost-effective treatment alternative in many regions.
• Market Opportunities: Emerging markets and combination therapies offer significant growth opportunities.

FAQs

What is the projected market size of saxagliptin by 2027?

The saxagliptin market is estimated to reach $255 million by 2027, growing at a CAGR of 4.17% during the forecast period 2022-2027[1].

What are the primary drivers of the saxagliptin market?

The primary drivers include the increasing prevalence of type 2 diabetes, clinical efficacy of saxagliptin, and government financing for healthcare[1][4].

Which region is expected to have the fastest CAGR in the saxagliptin market?

The Asia-Pacific region is expected to have the fastest CAGR over the forecast period due to the growing population and increasing healthcare spending in countries like India and China[1][4].

What are the common side effects associated with saxagliptin?

Common side effects include pancreatitis, heart failure, hypoglycemia, hypersensitivity reactions, and serious arthralgia[1].

How does saxagliptin compare to other second-line therapies in terms of cost-effectiveness?

Saxagliptin+metformin has been shown to be a cost-effective treatment alternative compared to other second-line therapies, such as acarbose+metformin, with lower costs and higher QALYs[5].

Sources

1. IndustryARC: Saxagliptin Market - Forecast(2024 - 2030) - IndustryARC
2. PMC: Retrospective Database Analysis Evaluating the Clinical Outcomes ...
3. Market.us: Incretin Mimetics Market Size, Share | CAGR Of 4.9%
4. MarkWideResearch: Saxagliptin Market 2024-2032 | Size, Share, Growth
5. PMC: Cost-Effectiveness of Saxagliptin versus Acarbose as Second-Line ...