Dapagliflozin; saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of patent protection?

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

Dapagliflozin; saxagliptin hydrochloride has three hundred and ten patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for dapagliflozin; saxagliptin hydrochloride

International Patents:	310
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
DailyMed Link:	dapagliflozin; saxagliptin hydrochloride at DailyMed

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.

Recent Clinical Trials for dapagliflozin; saxagliptin hydrochloride

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

Sponsor	Phase
University of Erlangen-Nürnberg Medical School	Phase 4
Sabyasachi Sen	Phase 4
Shenzhen Sixth People's Hospital	Phase 4

See all dapagliflozin; saxagliptin hydrochloride clinical trials

Pharmacology for dapagliflozin; saxagliptin hydrochloride

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; 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

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; 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	209091-001	Feb 27, 2017		RX	Yes	Yes			Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		RX	Yes	No			Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017		RX	Yes	Yes			Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		RX	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	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017

International Patents for dapagliflozin; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
New Zealand	574346	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
Lithuania	PA2020522
Hong Kong	1094951	包衣片製劑和方法 (COATED TABLET FORMULATION AND METHOD)
Poland	2139494

Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride

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
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116

Dapagliflozin; saxagliptin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dapagliflozin and Saxagliptin Hydrochloride

Introduction

Dapagliflozin and saxagliptin hydrochloride are two significant medications in the treatment of type 2 diabetes mellitus (T2DM). Understanding their market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Mechanism of Action and Clinical Use

Dapagliflozin

Dapagliflozin is an inhibitor of the sodium-glucose cotransporter 2 (SGLT2), which reduces renal reabsorption of glucose, leading to its increased urinary excretion. This mechanism helps in lowering blood glucose levels without increasing insulin secretion[1].

Saxagliptin Hydrochloride

Saxagliptin inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme, which slows the inactivation of incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This action enhances the release of insulin and decreases the release of glucagon, thereby improving glycemic control[1].

Market Size and Growth

Saxagliptin Market

The saxagliptin market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.17% from 2022 to 2027, with the market size estimated to reach $255 million by 2027. The 5 mg segment is expected to grow with the fastest CAGR of 4.8% during this period, driven by the increasing application of Onglyza 5 mg film-coated tablets[3].

Dapagliflozin Market

While specific market size projections for dapagliflozin alone are not detailed, its inclusion in combination therapies like Qtern (dapagliflozin and saxagliptin) and Xigduo (dapagliflozin and metformin) indicates a strong market presence. The growing prevalence of T2DM and the need for effective glycemic control drive the demand for these medications[2].

Geographical Distribution

Saxagliptin

The North American market accounted for the highest revenue share in 2021 and is expected to dominate the market during the forecast period. The Asia-Pacific region, however, is projected to have the fastest CAGR, driven by factors such as a proliferating population, increasing government financing, and rising healthcare spending in countries like India and China[3].

Dapagliflozin

Similar to saxagliptin, dapagliflozin's market is also influenced by regional healthcare needs and economic factors. Emerging markets like Brazil, Russia, India, China, and Turkey are key focus areas due to their growing middle class and increasing demand for quality healthcare[4].

Distribution Channels

Saxagliptin

The saxagliptin market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Online pharmacies held the largest market share in 2021, driven by the convenience and accessibility during the COVID-19 pandemic. Hospital pharmacies are expected to grow with the fastest CAGR of 4.9% as life returns to pre-pandemic normalcy[3].

Dapagliflozin

While specific distribution channel data for dapagliflozin is not provided, it is likely to follow a similar pattern to saxagliptin, with a significant presence in all three channels. The convenience of online pharmacies and the reliability of hospital pharmacies are expected to drive growth.

Financial Trajectory

Acquisition and Ownership

AstraZeneca's acquisition of Bristol-Myers Squibb's interests in their diabetes alliance in 2014 marked a significant financial milestone. AstraZeneca paid $2.7 billion in initial consideration and agreed to additional payments up to $1.4 billion in regulatory, launch, and sales-related payments until 2025[2].

Revenue Projections

The combined market for non-insulin anti-diabetic medicines, including dapagliflozin and saxagliptin, is driven by the growing prevalence of T2DM. With over 380 million people affected by diabetes in 2013 and a projected increase to over 592 million by 2035, the financial trajectory for these medications is positive[2].

Clinical Trials and Efficacy

Dapagliflozin and Saxagliptin in Pediatric Patients

A pivotal phase 3 trial (T2NOW) assessed the efficacy of dapagliflozin and saxagliptin in patients aged 10 to 17 years with T2DM. Dapagliflozin demonstrated significant reductions in HbA1c levels, while saxagliptin did not achieve statistical significance in the primary analysis at week 26[5].

Bioequivalence Studies

Bioequivalence studies for the fixed-dose combination (FDC) of saxagliptin and dapagliflozin (Qtern) showed that the FDC was bioequivalent to the free combination of the two drugs, indicating consistent pharmacokinetic profiles[1].

Safety and Side Effects

Dapagliflozin

Dapagliflozin is generally well-tolerated but can have side effects such as increased urinary tract infections and genital mycotic infections due to its mechanism of action[1].

Saxagliptin

Saxagliptin may bring about complexities like stroke and heart attack, which are major factors hampering its growth. However, it is also known for its efficacy in improving glycemic control with minimal risk of hypoglycemia[3].

Market Drivers

Increasing Prevalence of Diabetes

The growing prevalence of T2DM is a significant driver for the market. The disease affects over 380 million people worldwide and is projected to increase, driving the demand for effective treatments like dapagliflozin and saxagliptin[2].

Government Financing and Healthcare Spending

Increasing government financing and healthcare spending, particularly in emerging markets, are driving the growth of the saxagliptin and dapagliflozin markets[3][4].

Market Challenges

Regulatory and Intellectual Property Issues

Emerging markets present challenges such as intellectual property protection, currency volatility, and reimbursement issues, which must be addressed to capitalize on growth opportunities[4].

Side Effects and Safety Concerns

The potential side effects of these medications, such as increased risk of cardiovascular events with saxagliptin, can hamper market growth and necessitate careful risk management strategies[3].

Key Takeaways

• Growing Market: The market for dapagliflozin and saxagliptin is driven by the increasing prevalence of T2DM and is expected to grow significantly.
• Geographical Focus: North America and the Asia-Pacific region are key markets, with the latter expected to have the fastest growth rate.
• Distribution Channels: Online pharmacies and hospital pharmacies are crucial distribution channels.
• Financial Trajectory: The acquisition by AstraZeneca and the projected revenue from growing demand indicate a positive financial outlook.
• Clinical Efficacy: Both medications have shown efficacy in clinical trials, although with some safety concerns.

FAQs

Q: What is the mechanism of action of dapagliflozin?

A: Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), reducing renal reabsorption of glucose and increasing its urinary excretion[1].

Q: Which regions are expected to drive the growth of the saxagliptin market?

A: North America currently dominates the market, but the Asia-Pacific region is expected to have the fastest growth rate due to increasing population and healthcare spending[3].

Q: What are the potential side effects of saxagliptin?

A: Saxagliptin may increase the risk of stroke and heart attack, although it is generally effective in improving glycemic control with minimal risk of hypoglycemia[3].

Q: How does the bioequivalence of Qtern (dapagliflozin and saxagliptin) impact its market?

A: The bioequivalence of Qtern to the free combination of dapagliflozin and saxagliptin ensures consistent pharmacokinetic profiles, which is beneficial for patient treatment and market confidence[1].

Q: What are the key drivers for the market growth of these medications?

A: The increasing prevalence of T2DM, government financing, and rising healthcare spending in emerging markets are significant drivers for the growth of dapagliflozin and saxagliptin markets[2][3].

Sources

1. Clinical Evaluation Report for Saxagliptin and Dapagliflozin: Extract from the Clinical Evaluation Report for Qtern[1].
2. AstraZeneca Acquisition of Bristol-Myers Squibb's Diabetes Alliance: AstraZeneca press release, February 3, 2014[2].
3. Saxagliptin Market - Forecast(2024 - 2030): IndustryARC market research report[3].
4. Bristol-Myers Squibb Company Form 10-K: Filed February 19, 2010[4].
5. Safety, Growth, and Development After Dapagliflozin or Saxagliptin Administration: Journal of Clinical Endocrinology and Metabolism, October 24, 2024[5].