Sitagliptin - Generic Drug Details

What are the generic drug sources for sitagliptin and what is the scope of patent protection?

Sitagliptin is the generic ingredient in two branded drugs marketed by Zydus Lifesciences and Merck Sharp Dohme, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sitagliptin has four patent family members in four countries.

There are thirty-five drug master file entries for sitagliptin. Two suppliers are listed for this compound. There are seventeen tentative approvals for this compound.

Summary for sitagliptin

International Patents:	4
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	450
Patent Applications:	5,566
Drug Prices:	Drug price trends for sitagliptin
What excipients (inactive ingredients) are in sitagliptin?	sitagliptin excipients list
DailyMed Link:	sitagliptin at DailyMed

See drug prices for sitagliptin

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

Constraining patent/regulatory exclusivity:

10,925,871

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 sitagliptin

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

Sponsor	Phase
Diabetes & Endocrinology Foundation	N/A
Institute of Liver and Biliary Sciences, India	N/A
NeuroBo Pharmaceuticals Inc.	Phase 2

See all sitagliptin clinical trials

Generic filers with tentative approvals for SITAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL
		25MG	TABLET;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 sitagliptin

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

Anatomical Therapeutic Chemical (ATC) Classes for sitagliptin

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

US Patents and Regulatory Information for sitagliptin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-003	Oct 18, 2023		RX	Yes	Yes	10,925,871		Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006		RX	Yes	No

EU/EMA Drug Approvals for sitagliptin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Xelevia	sitagliptin	EMEA/H/C/000762 For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2007-03-21
Merck Sharp & Dohme B.V.	Tesavel	sitagliptin	EMEA/H/C/000910 For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination witha sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2008-01-10
Merck Sharp and Dohme B.V	Januvia	sitagliptin	EMEA/H/C/000722 For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2007-03-20
Merck Sharp & Dohme B.V.	Ristaben	sitagliptin	EMEA/H/C/001234 For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	no	no	no	2010-03-15
Accord Healthcare S.L.U.	Sitagliptin Accord	sitagliptin	EMEA/H/C/005598 For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.	Authorised	yes	no	no	2022-04-25

International Patents for sitagliptin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015128877
South Africa	201606075	PHARMACEUTICAL COMPOSITIONS OF SITAGLIPTIN
Philippines	12016501686	PHARMACEUTICAL COMPOSITIONS OF SITAGLIPTIN
India	651MU2014

Supplementary Protection Certificates for sitagliptin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	07C0041	France		PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
1412357	91360	Luxembourg		PRODUCT NAME: SITAGLIPTIN; AUTHORISATION NUMBER AND DATE: EU/1/07/383/001-018 20070323
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
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321

Sitagliptin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sitagliptin

Introduction to Sitagliptin

Sitagliptin, a novel oral incretin enhancer, is widely used in the management of type 2 diabetes mellitus. It works by inhibiting the dipeptidyl peptidase 4 enzyme, enhancing the body's natural response to glucose and improving glycemic control. Here, we delve into the market dynamics and financial trajectory of sitagliptin, highlighting its growth drivers, challenges, and future prospects.

Market Size and Forecast

The sitagliptin market is experiencing rapid growth, driven primarily by the increasing prevalence of type 2 diabetes globally. As of 2024, the sitagliptin market size was valued at USD 6.66 billion and is projected to reach USD 60.09 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 34.90% from 2024 to 2031[1].

Key Drivers of Market Growth

Rising Prevalence of Type 2 Diabetes

The global increase in type 2 diabetes cases is a significant driver of the sitagliptin market. As more individuals are diagnosed with type 2 diabetes, the demand for effective and well-tolerated antidiabetic medications like sitagliptin increases[1].

Focus on Diabetes Management

There is a heightened focus on diabetes management from both healthcare providers and patients. The need for better glycemic control and the prevention of diabetes-related complications drive the demand for medications like sitagliptin[1].

Favorable Regulatory Environment

A favorable regulatory environment also contributes to the market's growth. Regulatory approvals and guidelines that support the use of sitagliptin as an adjunct to other diabetes treatments have been instrumental in its adoption[1].

Market Segmentation

By Product Type

The sitagliptin market is segmented into injections and tablets. The injection segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[4].

By Application

The primary application of sitagliptin is in the management of type 2 diabetes. However, it is also explored for other uses, such as epilepsy, though diabetes remains the dominant segment[3].

By Geography

The market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. The Asia Pacific region, particularly countries like China, India, and Japan, accounts for the most significant share due to the growing prevalence of type 2 diabetes and expanding healthcare infrastructure[1].

Competitive Landscape

The sitagliptin market is highly competitive, with several major players including Merck & Co., Inc., Novartis AG, Eli Lilly and Company, AstraZeneca plc, and others. These companies are focusing on strategies to strengthen their product portfolios and expand their business in the global market[1][4].

Challenges and Restraints

Competition from Other Antidiabetic Drugs

The sitagliptin market faces competition from other classes of antidiabetic drugs such as metformin, sulfonylureas, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. This competition can impact the market share and growth potential of sitagliptin[1].

Safety Concerns

Concerns regarding the safety profile of sitagliptin, including rare cases of pancreatitis and hypersensitivity reactions, may also impact its adoption and utilization in specific patient populations[1].

Cost-Effectiveness Analysis

Studies have shown that sitagliptin can be either cost-saving or cost-effective when added to existing treatment regimens. For instance, adding sitagliptin to metformin is projected to be cost-effective for patients with type 2 diabetes who are not at HbA1C goal on metformin alone[5].

In a comparison with empagliflozin, another antidiabetic drug, sitagliptin was found to be less cost-effective in some scenarios, primarily due to higher drug costs associated with empagliflozin. However, empagliflozin's reduced rates of diabetes-related complications and increased survival rates made it a more cost-effective option in the long term[2].

Opportunities for Growth

Emerging Economies

There are significant opportunities for growth in emerging economies where the prevalence of type 2 diabetes is rapidly increasing. Rising healthcare expenditures, improving healthcare infrastructure, and increasing access to medications offer potential for market expansion in these regions[1].

Research and Development

Ongoing research and development efforts aimed at exploring novel uses, combination therapies, and new formulations of sitagliptin present opportunities for market growth and innovation[1].

Regional Analysis

Asia Pacific

The Asia Pacific region is the most significant market for sitagliptin, driven by the growing prevalence of type 2 diabetes in countries like China, India, and Japan. The expanding healthcare infrastructure and rising awareness about diabetes management in this region contribute to its growth[1].

North America and Europe

North America and Europe also represent substantial markets, with a high prevalence of type 2 diabetes and well-established healthcare systems. These regions are expected to continue contributing significantly to the global sitagliptin market[1].

Financial Analysis

The financial trajectory of the sitagliptin market is robust, with significant revenue growth anticipated over the forecast period. The market's CAGR of 34.90% from 2024 to 2031 indicates a strong financial outlook, driven by increasing demand and favorable market conditions[1].

Key Takeaways

• The sitagliptin market is driven by the growing prevalence of type 2 diabetes and a focus on effective diabetes management.
• The market is segmented by product type (injections and tablets) and application (primarily diabetes).
• Asia Pacific is the largest market due to the high prevalence of type 2 diabetes and expanding healthcare infrastructure.
• The market faces competition from other antidiabetic drugs and safety concerns.
• Ongoing research and development offer opportunities for growth and innovation.
• The financial outlook is strong, with a projected CAGR of 34.90% from 2024 to 2031.

FAQs

Q: What is the primary driver of the sitagliptin market? A: The primary driver of the sitagliptin market is the growing prevalence of type 2 diabetes globally.

Q: Which region accounts for the largest share of the sitagliptin market? A: The Asia Pacific region accounts for the largest share of the sitagliptin market.

Q: What are the main challenges faced by the sitagliptin market? A: The main challenges include competition from other antidiabetic drugs and safety concerns related to rare side effects.

Q: Is sitagliptin cost-effective compared to other antidiabetic drugs? A: Sitagliptin can be cost-effective in certain scenarios, especially when added to existing treatment regimens like metformin, but its cost-effectiveness can vary compared to other drugs like empagliflozin.

Q: What are the opportunities for growth in the sitagliptin market? A: Opportunities for growth include emerging economies, ongoing research and development, and exploring novel uses and formulations.

Cited Sources

1. Verified Market Research: Sitagliptin Market Size, Share, Scope, Trends, Analysis & Forecast.
2. PMC: Cost‐effectiveness analysis of empagliflozin versus sitagliptin as second‐line treatment to metformin for T2D patients.
3. Market Research Intellect: Sitagliptin Market Size, Share, Outlook, and Forecast.
4. Cognitive Market Research: Sitagliptin Market Report 2024 (Global Edition).
5. PubMed: Cost-effectiveness of sitagliptin-based treatment regimens for patients with type 2 diabetes.