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. Six 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 sixteen 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:	2
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	68
Patent Applications:	4,499
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
Ain Shams University	N/A
Beni-Suef University	Phase 4
Sabyasachi Sen	Phase 4

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
Croatia	P20161210
Czech Republic	304355	2-Azabicyklo[3.1.0.]hexan-3-karbonitrilová sloučenina, farmaceutický prostředek a použití (2-Azabicyclo [3.1.0]hexane-3-carbonitrile compound, pharmaceutical composition and use thereof)
Mexico	PA06013711	FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.)
Cyprus	1117813
Australia	2005249467	Coated tablet formulation and method

Supplementary Protection Certificates for ONGLYZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1261586	91985	Luxembourg		91985, EXPIRES: 20260305
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
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	CA 2012 00014	Denmark

ONGLYZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Onglyza (Saxagliptin)

Introduction

Onglyza, known generically as saxagliptin, is an oral anti-diabetic drug used primarily for the treatment of type 2 diabetes. It belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. Here, we will delve into the market dynamics and financial trajectory of Onglyza, highlighting key trends, drivers, and challenges.

Market Size and Growth

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

Key Market Drivers

Several factors drive the growth of the saxagliptin market:

Increasing Incidence of Diabetes

The rising incidence of type 2 diabetes, fueled by changing lifestyles, reduced physical exercise, and high obesity rates, is a major driver. As the global population becomes more prone to diabetes, the demand for effective treatments like saxagliptin increases[4].

Growing Risk Factors

Risk factors such as obesity, sedentary lifestyles, and dietary changes contribute to the increasing prevalence of diabetes, thereby boosting the demand for saxagliptin[4].

Complexity in Alternative Therapies

The complexities and limitations of alternative therapies for diabetes management make saxagliptin a preferred option, driving its market growth[4].

Market Segmentation

The saxagliptin market can be segmented in various ways:

By Dosage

The 5 mg segment is expected to grow with the fastest CAGR of 4.8% during the forecast period, driven by the heightened application of Onglyza 5 mg film-coated tablets[1].

By Distribution Channel

The market is segmented into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies. Online Pharmacies held the largest market share in 2021, largely due to the increased utilization of online pharmacies during global lockdowns[1].

Financial Performance of AstraZeneca

AstraZeneca, the manufacturer of Onglyza, has seen varied financial performances across different therapeutic areas:

Total Revenue

In 2023, AstraZeneca's total revenue, excluding COVID-19 medicines, increased by 15%. This growth was driven by strong performances in Oncology, Cardiovascular, Renal, and Metabolism (CVRM), Respiratory and Immunology (R&I), and Rare Disease segments[3][5].

Segment-wise Performance

• Oncology: Saw a significant increase of 19% in Q1 2023, contributing substantially to the overall revenue[3].
• CVRM: Experienced a 22% growth in Q1 2023, with drugs like Farxiga and Lokelma performing well[3].
• R&I: Grew by 8% in Q1 2023, with Fasenra and Breztri showing strong growth[3].

Impact on Onglyza

While the specific financial performance of Onglyza is not detailed in AstraZeneca's reports, the overall growth in the CVRM segment, where Onglyza is categorized, indicates a positive trend for the drug.

Challenges and Restraints

Despite the growth, the saxagliptin market faces several challenges:

Regulatory Framework

A strict regulatory framework for diabetic drugs can hinder market growth. Regulatory approvals and compliance requirements can be stringent and time-consuming[4].

Adverse Effects

Saxagliptin is associated with adverse effects such as upper respiratory tract infections, urinary tract infections, and headaches, which can restrain market growth[4].

Regional Market Dynamics

The market dynamics vary across different regions:

Emerging Markets

Emerging markets, particularly in Asia-Pacific and Latin America, Middle East, and Africa (LAMEA), offer significant growth opportunities due to increasing incidence of diabetes and growing healthcare infrastructure[4].

China

China is expected to return to growth, with a low single-digit percentage increase in revenue from pharmaceuticals, including saxagliptin, in FY 2023[3].

Innovative R&D Activities

Innovative research and development activities in diabetes therapeutics are crucial for the growth of the saxagliptin market. New formulations, combinations, and delivery methods can enhance the drug's efficacy and patient compliance.

Quotes from Industry Experts

Pascal Soriot, Chief Executive Officer of AstraZeneca, highlighted the company's strong start to 2023, with total revenue excluding COVID-19 medicines increasing by 15%. This indicates a positive outlook for the company's portfolio, including saxagliptin[3].

Illustrative Statistics

• Market Size: Estimated to reach $255 million by 2027[1].
• CAGR: 4.17% from 2022 to 2027[1].
• Online Pharmacies: Held the largest market share in 2021[1].
• AstraZeneca's Total Revenue: Increased by 15% in 2023, excluding COVID-19 medicines[3].

Key Takeaways

• The saxagliptin market is driven by increasing diabetes incidence and growing risk factors.
• The 5 mg segment is expected to grow at the fastest CAGR.
• Online pharmacies are a significant distribution channel.
• AstraZeneca's overall financial performance indicates a positive trend for saxagliptin.
• Regulatory and adverse effect challenges need to be addressed.
• Emerging markets offer significant growth opportunities.

FAQs

What is saxagliptin used for?

Saxagliptin, marketed as Onglyza, is used for the treatment of type 2 diabetes.

What are the key drivers of the saxagliptin market?

The key drivers include the increasing incidence of diabetes, growing risk factors, and complexities in alternative therapies.

What is the projected market size of saxagliptin by 2027?

The market size is estimated to reach $255 million by 2027.

Which segment is expected to grow the fastest in the saxagliptin market?

The 5 mg segment is expected to grow with the fastest CAGR of 4.8% during the forecast period.

What are the main challenges facing the saxagliptin market?

The main challenges include a strict regulatory framework and adverse effects associated with the drug.

Sources

1. IndustryARC, "Saxagliptin Market - Forecast(2024 - 2030) - IndustryARC"
2. AstraZeneca, "Full year and Q4 2022 results | AstraZeneca"
3. AstraZeneca, "Q1-2023-results-announcement.pdf - AstraZeneca"
4. Allied Market Research, "Saxagliptin Market Size, Share and Trends | Forecast by 2019 - 2026"
5. AstraZeneca, "AstraZeneca 8 February 2024 FY and Q4 2023 results Strong growth and pipeline momentum with three new medicines approved since the third quarter"