Metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details

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

Metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in two 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:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	61
Patent Applications:	360
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
UnitedHealthcare	PHASE2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
Sabyasachi Sen	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
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Mylan	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205981-001	Jul 31, 2023	AB	RX	No	No
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No			Y
Sun Pharm	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206081-001	Jul 31, 2023		DISCN	No	No
Mylan	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205981-003	Jul 31, 2023	AB	RX	No	No
Sun Pharm	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206081-002	Jul 31, 2023		DISCN	No	No
Dr Reddys Labs Sa	SAXAGLIPTIN AND METFORMIN 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	200678-002	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
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	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010

International Patents for metformin hydrochloride; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Croatia	P20160880
Spain	2754573
Poland	1753406
Spain	2593582
Portugal	2298288
South Korea	20070027560	COATED TABLET FORMULATION AND METHOD
China	1988891	Coated tablet formulation and method

Supplementary Protection Certificates for metformin hydrochloride; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	122008000046	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720

Market Dynamics and Financial Trajectory for Metformin Hydrochloride and Saxagliptin Hydrochloride

Last updated: July 27, 2025

Introduction

The landscape of pharmaceutical development, manufacturing, and commercialization is shaped by complex market dynamics that influence the financial trajectory of drugs such as Metformin Hydrochloride and Saxagliptin Hydrochloride. As key medications in the management of type 2 diabetes mellitus, these drugs represent significant market segments characterized by evolving regulatory environments, competitive pressures, and technological advancements. Understanding their market forces and financial prospects provides critical insights for industry stakeholders and investors.

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Market Overview of Metformin Hydrochloride and Saxagliptin Hydrochloride

Metformin Hydrochloride: A Paradigm in Diabetes Management

Metformin has been established as the first-line therapy for type 2 diabetes since its approval in the 1950s. Its affordability, combined with proven efficacy and safety profile, assures sustained demand. It acts primarily by reducing hepatic gluconeogenesis and improving insulin sensitivity. Its global market value is estimated to reach USD 5-6 billion annually, with growth driven by the rising prevalence of diabetes worldwide.

Saxagliptin Hydrochloride: A DPP-4 Inhibitor with Growth Potential

Saxagliptin, marketed under brand names such as Onglyza, is a dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the early 2010s. It acts by increasing incretin levels, thus enhancing insulin secretion. The DPP-4 class, including saxagliptin, has gained popularity for its oral administration and favorable tolerability. The global saxagliptin market is projected to grow at a CAGR of 7-9%, reaching USD 2-3 billion by the late 2020s.

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Market Dynamics Influencing Financial Trajectory

1. Rising Global Prevalence of Diabetes

According to the International Diabetes Federation (IDF), over 537 million adults lived with diabetes in 2021, expected to rise to 643 million by 2030. This demographic trend underpins the increased demand for both metformin and saxagliptin. Developing countries, notably India and China, exhibit the highest growth rates, enabling pharmaceutical companies to expand into emerging markets.

2. Regulatory and Reimbursement Environment

Regulatory agencies such as the FDA and EMA enforce stringent safety and efficacy standards, influencing drug approval and lifecycle management. Broad reimbursement policies facilitate patient access but vary significantly across regions, affecting sales revenue. For instance, metformin enjoys broad reimbursement globally, strengthening its market position, while newer drugs like saxagliptin face reimbursement hurdles that impact their financial trajectory.

3. Patent Cliff and Generic Competition

Metformin's patent expired decades ago, leading to a widespread generic market, which suppresses prices but sustains high volume. Meanwhile, saxagliptin's patent protections face expiration or are nearing their end, increasing the competitive landscape. Generics and biosimilars are expected to erode profit margins, prompting innovation and formulation strategies to sustain revenue.

4. Competitive Landscape and Drug Positioning

Metformin's status as an inexpensive, first-line therapy provides a size advantage but limits room for premium pricing. Conversely, saxagliptin competes with other DPP-4 inhibitors such as sitagliptin and linagliptin. Market positioning strategies—including combination formulations and patent extensions—are crucial for maintaining financial performance.

5. Technological and Therapeutic Advances

Emerging treatments like SGLT2 inhibitors and GLP-1 receptor agonists show promising efficacy in cardiovascular and renal outcomes; this influences prescribing trends. Both metformin and saxagliptin must adapt to incorporate these advances via combination therapies and real-world evidence to sustain relevance.

6. Impact of Patent Expiry and Biosimilar Entry

Patent expirations threaten revenue streams, especially for saxagliptin, which is still under patent protection in several markets. Biosimilar and generic entries will exert downward pressure on prices, necessitating strategic lifecycle management, such as pursuing new formulations or combination therapies to delay erosion.

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Financial Trajectory Analysis

Historical Performance

• Metformin has consistently generated high-volume sales buoyed by low pricing and generics. Global sales trends reflect resilience despite pricing pressures.
• Saxagliptin experienced modest growth post-launch but faced challenges due to competition and pricing theories, resulting in a more volatile financial profile.

Projected Growth Drivers

• Market Penetration & Expansion: Increasing adoption in developing markets and in combination therapies.
• Pricing Strategies: Premium pricing for innovative formulations or fixed-dose combinations (FDCs) bolster margins.
• Pipeline & Lifecycle Management: Developing new indications, formulations, and combination drugs sustains revenue streams amidst patent expirations.

Risks and Challenges

• Market Saturation: Widespread generic availability limits opportunities for premium pricing.
• Competitive Pressure: Entry of biosimilars and alternative therapies can erode market share.
• Regulatory Challenges: Stringent approval requirements could delay launches or restrict marketed indications.
• Pricing Reforms: Healthcare reforms aimed at cost containment could compress drug pricing.

Forecasts

• Metformin's revenue growth will likely be modest but stable, driven by volume.
• Saxagliptin's revenues will be highly sensitive to patent status, competitive dynamics, and formulation innovation. Short-term growth may plateau, but lifecycle extensions and combination formulations are expected to offset decreases post-patent expiration.

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Strategic Implications for Industry Stakeholders

• Investors should monitor patent landscapes, regulatory developments, and emerging therapeutic trends to evaluate long-term growth prospects.
• Pharmaceutical companies must prioritize R&D in combination therapies, novel formulations, and expanding indications.
• Policy-makers influence market dynamics via pricing regulations and reimbursement policies, necessitating adaptive strategies by industry players.

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Key Takeaways

• The global rise in diabetes prevalence underpins sustained demand for metformin and saxagliptin, though market growth will vary regionally.
• Patent expirations and increasing generic competition remain primary factors shaping the financial trajectory, advocating for lifecycle management and innovation.
• Market saturation for metformin fosters reliance on volume sales rather than pricing premiums, while saxagliptin’s growth depends on differentiating through formulations and indications.
• Emerging therapies and combination drugs are essential to preserve or augment financial performance amidst intense competition.
• Regulatory and reimbursement policies are pivotal in determining market access and profitability, requiring ongoing engagement and strategic adaptation.

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FAQs

1. How does patent expiration affect the revenue of metformin and saxagliptin?
Patent expiry typically leads to the entry of generic competitors, causing a significant reduction in prices and sales revenues. Metformin's off-patent status sustains high-volume, low-margin sales, while saxagliptin’s revenues may decline unless offset by new formulations or indications.

2. What market trends are expected to influence future growth of these drugs?
Key trends include increasing diabetes prevalence, technological innovations like fixed-dose combination therapies, and shifting treatment guidelines favoring certain drug classes. Advances in personalized medicine and combination drugs will be pivotal.

3. How do regulatory environments influence the financial trajectory of these drugs?
Regulatory approvals dictate market access, impact lifecycle management, and influence reimbursement eligibility. Stringent safety standards may delay approvals, while favorable policies can enhance market penetration and profitability.

4. What role does geographic expansion play in the financial outlook of these drugs?
Expanding into emerging markets offers opportunities for growth due to rising disease burden and unmet needs. Local pricing and reimbursement policies also shape revenue potential in these regions.

5. How can pharmaceutical companies mitigate revenue risks associated with patent cliffs?
By investing in research for new formulations, expanding indications, developing combination therapies, and pursuing lifecycle extension strategies, such as obtaining new patents or orphan status, companies can sustain revenues.

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Sources:
[1] International Diabetes Federation (IDF), 2021. "IDF Diabetes Atlas."
[2] MarketWatch. "Global Diabetes Drugs Market Size, Share & Trends Report."
[3] IQVIA. "Global Medicine Spending and Usage Trends," 2022.
[4] FDA. "Drug Approval and Patent Information," 2023.
[5] EvaluatePharma. "Forecast: Diabetes Market," 2022.