ONGLYZA Drug Patent Profile

When do Onglyza patents expire, and when can generic versions of Onglyza launch?

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.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. Three 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 fifteen 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

US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONGLYZA

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 and one FDA Regulatory Exclusivity.

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
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No			Y

International Patents for ONGLYZA

See the table below for patents covering ONGLYZA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	027634	INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV, METODO DE TRATAMIENTO Y COMPOSICION FARMACEUTICA.
Austria	396176
Australia	2001245466
Australia	4546601
Belgium	2010C008
Belgium	2012C016

Supplementary Protection Certificates for ONGLYZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	LUC00152	Luxembourg		PRODUCT NAME: 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
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1261586	CA 2012 00014	Denmark
2139494	LUC00176	Luxembourg		PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
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
1261586	91650	Luxembourg		91650, EXPIRES: 20241001

Last updated: February 10, 2026

What Are the Investment Drivers for Onglyza (Saxagliptin)?

Onglyza (saxagliptin) is a diabetic medication developed by AstraZeneca, marketed globally with a focus on type 2 diabetes management. It is a DPP-4 inhibitor approved by the FDA in 2009. The drug’s sales are driven by the global prevalence of type 2 diabetes, rising healthcare expenditure, and expanding indications.

Market Size and Growth Potential

• Global Diabetes Market: Estimated at $70 billion in 2022, projected to expand at a CAGR of 6-7% through 2027[1].
• Type 2 Diabetes Prevalence: Expected to reach 700 million worldwide by 2045[2].
• Onglyza's Market Share: Historically registered as one of the top DPP-4 inhibitors, with peak sales of approximately $1.2 billion in 2017 before patent expirations affected revenue[3].

Patent Status and Competition

• Patent Expiry: Patents expired in the U.S. in 2022, opening the market to biosimilars and generics, leading to a sharp decline in sales[4].
• Competitive Landscape: Includes Januvia (sitagliptin), Tradjenta (linagliptin), and newer drugs like SGLT2 inhibitors (e.g., Jardiance, Invokana). Entry of biosimilars reduces Onglyza's pricing power.

Pipeline and Regulatory Landscape

• Additional Indications: Investigational uses include combination therapies and cardiovascular risk reduction.
• Regulatory Challenges: Post-marketing safety concerns, including heart failure risk, led to warnings that may influence market acceptance[5].

What Are the Fundamental Financials for Onglyza?

Fiscal performance has declined significantly due to patent cliffs and market competition.

Revenue Trends

Year	Revenue (USD millions)	Change (YoY)
2017	1,200	-
2018	800	-33%
2019	350	-56%
2020	180	-49%
2021	120	-33%

The revenue decline corresponds with patent expiration and increased generic competition.

Cost and Profitability

• Cost of Goods Sold (COGS): Approx. 30% of revenue.
• Research & Development (R&D): Prior to patent expiry, AstraZeneca invested roughly $300 million annually in metabolic disease research; R&D costs have declined with the drug's revenue base[6].
• Gross Margin: Historically around 70% pre-patent expiry; has dropped below 50% as sales declines.

Cash Flow and Profitability

• Operating Margin: Negative in recent years, reflecting sales decline.
• Free Cash Flow: Has been negative since 2018, limiting funds for pipeline expansion.
• Balance Sheet: AstraZeneca maintains a strong cash position (~$4 billion in cash reserves), providing flexibility for pipeline investment and acquisitions[7].

How Do External Factors Influence Onglyza’s Investment Fundamentals?

Regulatory Environment

• Safety Warnings: Heart failure risk warnings issued by FDA in 2017 impacted sales[5].
• Market Entry Barriers: Patent expirations open opportunities for biosimilars; regulatory pathways for generics are well-established, reducing market exclusivity.

Market Acceptance and Prescribing Trends

• Physician Preference: Shift toward SGLT2 inhibitors and GLP-1 receptor agonists due to emerging cardiovascular and renal benefits.
• Patient Factors: Increased focus on cardiovascular safety profiles influences drug selection.

Pricing and Reimbursement

• Pricing Pressure: Increased by biosimilars and generics.
• Reimbursement Landscape: Tighter controls in key markets like the U.S. and Europe affect profitability.

What Are the Investment Risks?

• Patent Loss: Major risk for revenue erosion.
• Market Share Loss: Due to newer, more effective, or safer treatments.
• Safety Concerns: Post-marketing safety issues can lead to restrictions or withdrawal.
• Pipeline Limitations: Limited pipeline development specific to Onglyza increases dependency on other assets for future growth.

What Are Potential Strategic Opportunities?

• Combination Therapies: Co-formulations with SGLT2 inhibitors or GLP-1 agonists could revitalize sales[8].
• New Indications: Cardiovascular or renal protective effects could expand the label.
• Acquisition or Licensing: Partnering with or acquiring companies with complementary drugs could mitigate revenue declines.

Key Takeaways

• Onglyza's sales peaked pre-2018 and declined sharply following patent expiration.
• Competitive and safety issues diminish its future growth prospects.
• AstraZeneca's strong balance sheet allows potential strategic moves but does not offset revenue declines.
• Market shifts toward SGLT2 inhibitors and GLP-1 receptor agonists challenge the drug's relevance.
• Pipeline efforts and combination therapies present potential but remain uncertain.

FAQs

1. Will Onglyza recover market share?
Likely not, due to strong competition from newer agents and patent expiry.

2. What is the outlook for Onglyza’s revenues?
Revenues are approaching zero in key markets, with negligible contribution expected unless new indications or formulations emerge.

3. How does biosimilar competition affect Onglyza?
It accelerates pricing erosion and market loss, especially in Europe and the U.S.

4. Are there ongoing efforts to extend Onglyza’s lifecycle?
Yes, through combination therapies and new indications, but success remains uncertain.

5. Should investors consider AstraZeneca’s other diabetes assets?
Yes, assets like Farxiga (dapagliflozin) and Trulicity (dulaglutide) show growth potential and are prioritized in AstraZeneca’s portfolio.

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Sources

1. Grand View Research, "Diabetes Drugs Market Size, Share & Trends," 2022.
2. International Diabetes Federation, "IDF Diabetes Atlas," 9th Ed., 2019.
3. AstraZeneca, Annual Reports, 2017–2021.
4. U.S. Patent and Trademark Office, "Patent Listings for Saxagliptin," 2022.
5. FDA, "Warnings and Safety Communications," 2017.
6. AstraZeneca, "Research & Development Expenses," 2022.
7. AstraZeneca, Financial Statements, 2022.
8. Industry reports on combination therapy trends, 2022.