METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details

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

Metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in three branded drugs marketed by Astrazeneca Ab, Dr Reddys Labs Sa, Mylan, and Sun Pharm, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.

Three suppliers are listed for this compound.

Summary for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

International Patents:	57
US Patents:	2
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	60
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
DailyMed Link:	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

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

Sponsor	Phase
Sabyasachi Sen	Phase 4
Dongguan Kanghua Hospital	Phase 4
Third Affiliated Hospital, Sun Yat-Sen University	Phase 4

See all METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials

Pharmacology for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KOMBIGLYZE XR	Extended-release Tablets	metformin hydrochloride; saxagliptin hydrochloride	5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg	200678	3	2013-07-31

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205981-002	Jul 31, 2023	AB	RX	No	No
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Dr Reddys Labs Sa	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207678-002	Aug 9, 2023	AB	RX	No	No

Expired US Patents for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010

International Patents for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	102895208	Coated tablet formulation and method
Montenegro	02516	FORMULACIJA I METOD OBLOŽENE TABLETE (COATED TABLET FORMULATION AND METHOD)
Ukraine	88168	ПРЕПАРАТ В ВИДЕ ТАБЛЕТКИ САКСАГЛИПТИНА С ПОКРЫТИЕМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ;ПРЕПАРАТ У ВИГЛЯДІ ТАБЛЕТКИ САКСАГЛІПТИНУ З ПОКРИТТЯМ І СПОСІБ ЙОГО ВИГОТОВЛЕННЯ (COATED TABLET FORMULATION COMPRISING SAXAGLIPITIN AND METHOD FOR FORMING THEREOF)

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2498758	PA2020003,C2498758	Lithuania		PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metformin Hydrochloride and Saxagliptin Hydrochloride

Introduction to Metformin and Saxagliptin

Metformin hydrochloride and saxagliptin hydrochloride are two crucial medications used in the management of type 2 diabetes mellitus (T2DM). Metformin is a first-line treatment for T2DM, while saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor often used in combination with metformin to enhance glycemic control.

Market Overview of Saxagliptin

The saxagliptin market is projected to grow significantly over the forecast period of 2022-2027. Here are some key points:

• Market Size and Growth: The saxagliptin market is estimated to reach $255 million by 2027, growing at a CAGR of 4.17% during the forecast period[1].
• Dosage Segments: The market is segmented into 2.5 mg and 5 mg tablets, with the 5 mg segment expected to grow at the fastest CAGR of 4.8% due to the increasing use of Onglyza 5 mg film-coated tablets[1].

Market Drivers

Several factors are driving the growth of the saxagliptin market:

• Increasing Prevalence of Diabetes: The rising incidence of type 2 diabetes, driven by factors such as changing lifestyles, reduced physical exercise, and high obesity rates, is a significant driver[2].
• Government Financing and Healthcare Spending: Increased government financing and healthcare spending on research and development (R&D) in diabetes therapeutics are propelling market growth[1].
• Emerging Economies: Growth opportunities in emerging economies, particularly in the Asia-Pacific region, are expected to contribute to the market's expansion[2].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

• Adverse Effects: Saxagliptin can cause adverse effects such as upper respiratory tract infections, urinary tract infections, and headaches, which may hamper market growth[2].
• Regulatory Framework: A strict regulatory framework for diabetic drugs can also act as a restraint[2].

Distribution Channels

The saxagliptin market is segmented by distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies.

• Online Pharmacies: Online pharmacies held the largest market share in 2021, driven by the convenience and increased use during the COVID-19 pandemic[1].
• Hospital Pharmacies: Hospital pharmacies are expected to grow with the fastest CAGR of 4.9% as life returns to pre-pandemic normalcy[1].

Geographical Segmentation

Geographically, the saxagliptin market is segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World.

• North America: This region held the largest share with 36.4% of the overall market in 2021, driven by the increasing prevalence of type 2 diabetes and a large elderly population[1].
• Asia-Pacific: This region is expected to have the fastest CAGR during the forecast period due to a growing population and increasing healthcare spending in countries like India and China[1].

Combination Therapies

Saxagliptin is often used in combination with metformin, and this combination is gaining traction:

• Kombiglyze FDC: The fixed-dose combination (FDC) of saxagliptin and metformin, known as Kombiglyze, is approved in several countries. This combination offers a more convenient dosing regimen and has been shown to be effective in clinical trials[4].
• Qternmet XR: Another combination therapy, Qternmet XR, which includes dapagliflozin, saxagliptin, and metformin hydrochloride, has been approved in the US. This once-daily oral medication has demonstrated significant reductions in HbA1c levels in clinical trials[5].

Clinical Efficacy

Clinical trials have shown the efficacy of saxagliptin in improving glycemic control:

• HbA1c Reduction: Studies have demonstrated statistically significant decreases in HbA1c levels when saxagliptin is used in combination with metformin and other medications[5].
• Pharmacokinetic and Pharmacodynamic Data: The bioequivalence of the FDC product with its component substances has been established, and the twice-daily dosing regimen of saxagliptin has been justified through pharmacodynamic data[4].

Key Players

Major pharmaceutical companies are involved in the development and marketing of these medications:

• AstraZeneca: AstraZeneca is a key player, with products like Qternmet XR and Kombiglyze XR, which are part of their Cardiovascular, Renal & Metabolism (CVRM) therapy area[5].
• Bristol-Myers Squibb Company: This company is also a significant player in the saxagliptin market[2].

Financial Trajectory

The financial trajectory of the saxagliptin market is positive, driven by increasing demand and innovative R&D activities:

• Market Size: The market is expected to reach $255 million by 2027, indicating a steady growth trajectory[1].
• Revenue Share: North America currently holds the largest revenue share, but the Asia-Pacific region is expected to grow rapidly[1].

Future Outlook

The future outlook for the saxagliptin market is promising, with several factors contributing to its growth:

• Innovative R&D: Continuous R&D activities in diabetes therapeutics will drive market growth[1].
• Emerging Markets: The growing healthcare needs in emerging economies will provide significant growth opportunities[2].

Key Takeaways

• The saxagliptin market is expected to grow at a CAGR of 4.17% from 2022 to 2027.
• Combination therapies with metformin and other medications are gaining traction.
• North America currently dominates the market, but the Asia-Pacific region is expected to grow rapidly.
• Innovative R&D and increasing healthcare spending are key drivers of market growth.
• Adverse effects and regulatory frameworks are potential restraints.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of saxagliptin by 2027? A: The saxagliptin market is estimated to reach $255 million by 2027[1].

Q: Which dosage segment of saxagliptin is expected to grow the fastest? A: The 5 mg segment is expected to grow with the fastest CAGR of 4.8% during the forecast period[1].

Q: What are the main distribution channels for saxagliptin? A: The main distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies, with online pharmacies holding the largest market share in 2021[1].

Q: Which region is expected to have the fastest CAGR in the saxagliptin market? A: The Asia-Pacific region is expected to have the fastest CAGR during the forecast period[1].

Q: What are the common combination therapies involving saxagliptin? A: Saxagliptin is often used in combination with metformin (Kombiglyze) and also with dapagliflozin and metformin (Qternmet XR)[4][5].