Dapagliflozin - Generic Drug Details

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

Dapagliflozin is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in four NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has four hundred and forty patent family members in fifty-one countries.

There are twenty-six drug master file entries for dapagliflozin. Five suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Summary for dapagliflozin

International Patents:	440
US Patents:	27
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	427
Patent Applications:	3,227
Drug Prices:	Drug price trends for dapagliflozin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin
What excipients (inactive ingredients) are in dapagliflozin?	dapagliflozin excipients list
DailyMed Link:	dapagliflozin at DailyMed

See drug prices for dapagliflozin

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

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.

Recent Clinical Trials for dapagliflozin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yale University	Phase 1
American Heart Association	Phase 2
Yale University	Phase 2

See all dapagliflozin clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, EXTENDED RELEASE;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 dapagliflozin

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FARXIGA	Tablets	dapagliflozin	5 mg and 10 mg	202293	20	2018-01-08

US Patents and Regulatory Information for dapagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No			Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes

Expired US Patents for dapagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014

EU/EMA Drug Approvals for dapagliflozin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Forxiga	dapagliflozin	EMEA/H/C/002322 Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2012-11-11
AstraZeneca AB	Edistride	dapagliflozin	EMEA/H/C/004161 Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2015-11-09
Viatris Limited	Dapagliflozin Viatris	dapagliflozin	EMEA/H/C/006006 Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.	Authorised	yes	no	no	2023-03-24

International Patents for dapagliflozin

Country	Patent Number	Title	Estimated Expiration
Mexico	339143	SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.)
Poland	2508188
Japan	2015044831	糖尿病の治療法および体重の減少法 (METHODS FOR TREATING DIABETES AND METHODS FOR REDUCING BODY WEIGHT)
Austria	E531374

Supplementary Protection Certificates for dapagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	2090034-6	Sweden		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719
2139494	34/2020	Austria		PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112

Dapagliflozin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dapagliflozin

Introduction

Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been a significant player in the pharmaceutical market, particularly in the treatment of type 2 diabetes and heart failure. Here, we delve into the market dynamics and financial trajectory of dapagliflozin, highlighting its growth, cost-effectiveness, and future projections.

Market Growth and Projections

The market for dapagliflozin has experienced substantial growth in recent years and is expected to continue this trend. The global market size for empagliflozin, dapagliflozin, and canagliflozin is projected to grow from $9.41 billion in 2023 to $9.64 billion in 2024, with a compound annual growth rate (CAGR) of 2.4%. By 2028, the market is anticipated to reach $10.78 billion at a CAGR of 2.8%[4].

Drivers of Market Growth

Several factors are driving the growth of the dapagliflozin market:

Increasing Prevalence of Type 2 Diabetes

The global increase in the prevalence of type 2 diabetes is a significant driver. As more people are diagnosed with diabetes, the demand for effective treatments like dapagliflozin rises[4].

Growing Awareness and Benefits

Increased awareness about the benefits of SGLT2 inhibitors, such as dapagliflozin, has led to higher adoption rates among healthcare providers and patients. These drugs offer not only glycemic control but also cardiovascular benefits, which are highly valued[4].

Elderly Population Growth

The growth in the elderly population, who are more prone to diabetes and heart failure, also contributes to the increasing demand for dapagliflozin[4].

Focus on Personalized Medicine

The increasing focus on personalized medicine and combination therapies further boosts the market. Dapagliflozin is often used in combination with other medications to provide comprehensive treatment plans[4].

Cost-Effectiveness

The cost-effectiveness of dapagliflozin is a crucial aspect of its market dynamics.

Heart Failure Treatment

Studies such as the DAPA-HF trial have shown that dapagliflozin reduces cardiovascular mortality and hospitalizations due to heart failure, improving patient-reported health status. However, the cost-effectiveness varies based on the cost of the drug. For instance, if the cost of dapagliflozin decreases by 43% (from $474 to $270), the cost per quality-adjusted life year (QALY) gained would drop below $50,000, making it more cost-effective[2].

European Health-Economic Analysis

A European health-economic analysis based on the DELIVER trial found that dapagliflozin, added to usual care, is very likely cost-effective for heart failure with mildly reduced or preserved ejection fraction in several European countries. The incremental cost-effectiveness ratios were favorable, with 91%, 89%, and 92% of simulations in the UK, Germany, and Spain, respectively, being cost-effective[5].

Financial Trajectory

The financial trajectory of dapagliflozin is marked by steady revenue growth and significant market expansion.

Revenue Projections

The pharmaceutical grade dapagliflozin market is expected to experience robust growth rates over the forecast period from 2023 to 2031, driven by its expanding applications and increasing demand[1].

Market Size and Growth

The global empagliflozin, dapagliflozin, and canagliflozin market size is expected to see steady growth, driven by increasing demand for oral diabetes medications, investments in diabetes research, and rising healthcare expenditure[4].

Regional Market Analysis

The market for dapagliflozin varies by region, with different factors influencing its growth.

Asia-Pacific

The Asia-Pacific region is a significant market due to the large population and increasing prevalence of diabetes. Government initiatives, regulations, and investments in healthcare infrastructure are key drivers in this region[4].

North America and Europe

In North America and Europe, the market is driven by advanced healthcare systems, high awareness of SGLT2 inhibitors, and a strong focus on personalized medicine. These regions also see significant investments in diabetes research and drug development[4].

Challenges and Opportunities

While the market for dapagliflozin is growing, there are challenges and opportunities to consider:

Challenges

• Cost and Affordability: The high cost of dapagliflozin can be a barrier to access, especially in regions with limited healthcare budgets. A reduction in the cost of the drug could significantly improve its cost-effectiveness[2][3].
• Regulatory Environment: Changes in regulatory policies and healthcare reimbursement strategies can impact the market dynamics[4].

Opportunities

• Technological Advancements: Advances in healthcare technology, such as telehealth and health data analytics, can enhance the delivery and monitoring of dapagliflozin treatment[4].
• Combination Therapies: The potential for combination therapies involving dapagliflozin offers new market opportunities and can improve treatment outcomes[4].

Key Takeaways

• Market Growth: The dapagliflozin market is expected to grow significantly, driven by increasing demand for SGLT2 inhibitors and expanding applications.
• Cost-Effectiveness: Dapagliflozin is cost-effective, particularly when its cost is reduced, and it offers significant health benefits in heart failure and diabetes treatment.
• Regional Variations: Market dynamics vary by region, with factors such as government initiatives, healthcare infrastructure, and awareness of SGLT2 inhibitors influencing growth.
• Challenges and Opportunities: While cost and regulatory challenges exist, technological advancements and the potential for combination therapies present opportunities for further market growth.

FAQs

Q: What is the expected market size for dapagliflozin in the coming years? A: The global market size for empagliflozin, dapagliflozin, and canagliflozin is expected to grow from $9.41 billion in 2023 to $10.78 billion by 2028[4].

Q: How cost-effective is dapagliflozin in treating heart failure? A: Dapagliflozin is considered cost-effective, especially when its cost is reduced. For instance, a 43% decrease in cost can bring the cost per QALY gained below $50,000[2].

Q: What are the main drivers of the dapagliflozin market growth? A: The main drivers include the increasing prevalence of type 2 diabetes, growing awareness of SGLT2 inhibitors, growth in the elderly population, and a focus on personalized medicine[4].

Q: How does the regional market for dapagliflozin vary? A: The market varies significantly by region, with factors such as government initiatives, healthcare infrastructure, and awareness of SGLT2 inhibitors influencing growth in regions like Asia-Pacific, North America, and Europe[4].

Q: What are the potential challenges facing the dapagliflozin market? A: Challenges include the high cost of the drug, regulatory changes, and healthcare reimbursement strategies. However, technological advancements and combination therapies offer opportunities for growth[4].

Sources

1. Market Research Intellect: Global Pharmaceutical Grade Dapagliflozin Market Size, Trends and ...
2. PubMed: Cost-effectiveness of Dapagliflozin for Treatment of Patients With ...
3. Frontiers in Pharmacology: Cost-Effectiveness of Canagliflozin Versus Dapagliflozin Added to ...
4. The Business Research Company: Empagliflozin, Dapagliflozin And Canagliflozin Market Report 2024 ...
5. Wiley Online Library: The cost‐effectiveness of dapagliflozin in heart failure with ...