dapagliflozin; saxagliptin hydrochloride - Profile

What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; saxagliptin hydrochloride has two hundred and fifty-six patent family members in forty-eight countries.

Summary for dapagliflozin; saxagliptin hydrochloride

International Patents:	256
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; saxagliptin hydrochloride

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; saxagliptin hydrochloride

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	5 mg/5 mg	209091	1	2020-07-29
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	10 mg/5 mg	209091	5	2018-01-08

US Patents and Regulatory Information for dapagliflozin; 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	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		DISCN	Yes	No					Y

Expired US Patents for dapagliflozin; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019

International Patents for dapagliflozin; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2985797
Mexico	2008015377
Hungary	0300393	C-aril glükozid SGLT2 inhibitorok és alkalmazásuk, valamint ezeket tartalmazó gyógyszerkészítmények (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND THEIR USE AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)
Eurasian Patent Organization	200900066
Brazil	122017021516
Brazil	122017015098
Canada	2388818	INHIBITEURS DE SGLT2 A BASE DE GLUCOSIDE C-ARYLE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS)

Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211	C20140021 00131	Estonia		PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211	1390017-0	Sweden		PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	588	Finland
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715

Dapagliflozin; saxagliptin hydrochloride Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the Investment Outlook for Dapagliflozin and Saxagliptin Hydrochloride?

Dapagliflozin and saxagliptin hydrochloride are two established drugs in the treatments of type 2 diabetes mellitus (T2DM). Dapagliflozin is an SGLT2 inhibitor, marketed by AstraZeneca, while saxagliptin is a DPP-4 inhibitor, marketed by AstraZeneca and others. Their combined potential in combination therapies and ongoing pipeline developments influence their investment profiles.

What Are the Market Drivers and Competitive Landscape?

Market Size and Growth

The global T2DM drug market was valued at approximately $65 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 7% until 2030 [1].

Key Competitive Factors

• Efficacy and safety profiles
• Cardiovascular and renal benefits
• Regulatory approvals and label expansions
• Patent expirations and biosimilar threats
• Pricing and reimbursement policies

Current Position

Dapagliflozin accounted for roughly 20% of the global SGLT2 inhibitor market in 2022, with sales of approximately $4.2 billion [2]. Saxagliptin's market share in DPP-4 inhibitors was similar, with sales around $2.8 billion.

Pipeline and Lifecycle Status

• Dapagliflozin has received additional approvals for heart failure and chronic kidney disease.
• Saxagliptin’s patent expires in the U.S. in 2027, with biosimilar competition anticipated afterward.

What Are the Financial and Regulatory Fundamentals?

Dapagliflozin

• Approved for T2DM, heart failure, and CKD
• Sales peaked at around $4.2 billion in 2022
• Facing competition from similar drugs like empagliflozin and canagliflozin
• Patent expiration: 2028 in U.S.
• Ongoing research into combo formulations and new indications

Saxagliptin Hydrochloride

• Approved for T2DM
• Sales around $2.8 billion in 2022
• Patent expiry: 2027 (U.S.)
• Under patent expiry pressure, with biosimilar entries expected by 2028
• Used in combination therapies to enhance outcomes

License and Patent Landscape

• Both drugs benefit from extensive IP protections, but patent cliffs loom
• AstraZeneca holds primary patents until late 2020s
• Primary generic threats expected post-2027

R&D Investments and Pipeline

• Dapagliflozin: continuous expansion into renal and cardiovascular markets
• Saxagliptin: potential reformulations and novel delivery systems under R&D
• Broader strategic focus on combination therapies

What Are the Investment Risks and Opportunities?

Risks

• Patent expiration leading to generic erosion
• Regulatory hurdles in new indications
• Competitive innovation from new drug classes (e.g., GLP-1 receptor agonists)
• Pricing pressures and reimbursement cuts globally
• Clinical trial failures or safety concerns

Opportunities

• Expansion of indications, notably renal and cardiovascular benefits
• Growth in market penetration in emerging economies
• Adoption in combination therapies, leveraging synergistic efficacy
• Pipeline advancements and lifecycle management strategies

How Do Policy and Reimbursement Policies Affect These Drugs?

• The push for value-based healthcare increases pressure on price controls
• Reimbursement policies favor drugs with proven cardiovascular and renal benefits
• International variations affect market access and pricing
• Patent corridors may extend market exclusivity in certain markets with legal strategies

What Is the Future Outlook?

Both dapagliflozin and saxagliptin are likely to sustain their market share within the T2DM therapeutics space due to ongoing indication extensions, combination treatments, and broadening of patient populations. However, the approach to patent expiry and biosimilar entry will significantly influence their long-term revenue streams.

Key Takeaways

• Dapagliflozin and saxagliptin occupy significant segments in the T2DM market.
• Their future growth depends on clinical benefits, regulatory approvals, and patent protections.
• Patent expiries from 2027 to 2028 pose price erosion risks.
• Opportunities lie in expanding into cardiovascular and renal indications.
• Competitive landscape shifting with generics and innovation must be monitored.

FAQs

1. How significant is patent expiration risk for these drugs?
Patent expiry in the U.S. is expected around 2027-2028, which could lead to generic competition and substantial revenue decline unless offset by new indications or formulations.

2. What are the key drivers of growth in the T2DM drug market?
Improvements in cardiovascular and renal outcomes, combination therapies, and the increasing prevalence of T2DM globally drive market growth.

3. How do regulatory approvals affect investment prospects?
Approvals for additional indications, such as heart failure, can sustain or boost sales margins, while delays or denials can negatively impact outlooks.

4. What are the opportunities for lifecycle extension?
Development of fixed-dose combination pills, reformulations, and new delivery systems, along with expanding into underserved markets.

5. Which competitors threaten the market shares of dapagliflozin and saxagliptin?
Other SGLT2 inhibitors (empagliflozin, canagliflozin) and DPP-4 inhibitors (sitagliptin, linagliptin), as well as emerging drug classes like GLP-1 receptor agonists.

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References

1. MarketsandMarkets. "Diabetes Drugs Market by Class." 2022.
2. EvaluatePharma. "Global SGLT2 Inhibitors Market Review." 2022.