Sitagliptin phosphate - Generic Drug Details

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

Sitagliptin phosphate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sitagliptin phosphate has fifty-two patent family members in forty countries.

There are thirty-four drug master file entries for sitagliptin phosphate. Three suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Summary for sitagliptin phosphate

International Patents:	52
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	44
Patent Applications:	114
Drug Prices:	Drug price trends for sitagliptin phosphate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sitagliptin phosphate
DailyMed Link:	sitagliptin phosphate at DailyMed

See drug prices for sitagliptin phosphate

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

Constraining patent/regulatory exclusivity:

7,326,708*PED

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 phosphate

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

Sponsor	Phase
Galenicum Health	Phase 1
The Affiliated Hospital of Qingdao University	Phase 1
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all sitagliptin phosphate clinical trials

Generic filers with tentative approvals for SITAGLIPTIN PHOSPHATE

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 phosphate

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

Medical Subject Heading (MeSH) Categories for sitagliptin phosphate

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Anatomical Therapeutic Chemical (ATC) Classes for sitagliptin phosphate

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 SITAGLIPTIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUVIA	Tablets	sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	021995	1	2012-11-06
JANUVIA	Tablets	sitagliptin phosphate	100 mg/20 mg	021995	1	2012-06-25
JANUVIA	Tablets	sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	021995	1	2012-06-19
JANUVIA	Tablets	sitagliptin phosphate	25 mg, 50 mg and 100 mg	021995	6	2010-10-18

US Patents and Regulatory Information for sitagliptin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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	021995-002	Oct 16, 2006		RX	Yes	No
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	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
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No

Expired US Patents for sitagliptin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,890,898
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	6,890,898
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	7,459,428

International Patents for sitagliptin phosphate

Country	Patent Number	Title	Estimated Expiration
Cyprus	1106936
South Africa	200509933	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Costa Rica	8117	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
Australia	2004253889	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Dominican Republic	P2004000941	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
Colombia	5660266	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
South Korea	20060026061	PHOSPHORIC ACID SALT OF A DIPEPTIDYL-PEPTIDASE-IV INHIBITOR

Supplementary Protection Certificates for sitagliptin phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	PA2007006,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
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	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
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
1412357	C300287	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321

Sitagliptin phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sitagliptin Phosphate

Introduction to Sitagliptin Phosphate

Sitagliptin phosphate, commonly known by its brand name JANUVIA, is a widely used medication for the treatment of type 2 diabetes. It belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors, which help in regulating blood glucose levels by increasing the levels of incretin hormones.

Market Size and Growth Projections

The sitagliptin phosphate market has been experiencing significant growth, driven by several key factors. As of 2024, the sitagliptin market 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% during this period[4].

Drivers of Market Growth

Rising Prevalence of Type 2 Diabetes

The increasing global prevalence of type 2 diabetes is a major driver of the sitagliptin market. As the number of individuals with type 2 diabetes continues to rise, there is a growing demand for effective and well-tolerated antidiabetic medications like sitagliptin[4].

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 to help achieve and maintain target blood glucose levels[4].

Favorable Regulatory Environment

A favorable regulatory environment also contributes to the market's growth. Regulatory approvals and guidelines that support the use of sitagliptin in various treatment protocols enhance its market attractiveness[4].

Market Segmentation

By Type

The sitagliptin phosphate API market is segmented based on the purity levels of the API, such as above 98% and above 99%. This segmentation helps in understanding the demand for different purity levels in various applications[1].

By Application

The market is also segmented by application, primarily into tablets and other forms. The majority of sitagliptin is used in the production of tablets due to its efficacy and ease of administration[1].

By Geography

Geographically, the market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region, particularly countries like China, India, and Japan, accounts for a significant share of the global sitagliptin market due to the growing prevalence of type 2 diabetes and expanding healthcare infrastructure[4].

Market Dynamics

Drivers

• Therapeutic Efficacy: Sitagliptin has been shown to effectively enhance therapeutic outcomes in diabetic patients, maintaining stable blood glucose levels and reducing the incidence of adverse reactions compared to other medications[2].
• Cost-Effectiveness: The cost-effectiveness of sitagliptin is another significant driver. Studies have indicated that sitagliptin offers a satisfactory cost-effectiveness ratio, making it a preferred choice for long-term treatment[2].

Restraints

• Competitive Landscape: The presence of other antidiabetic medications, such as liraglutide, which has shown superior efficacy in some studies, can pose a challenge to the market growth of sitagliptin[5].
• Regulatory Challenges: Changes in regulatory environments or the introduction of new guidelines can impact the market dynamics and adoption rates of sitagliptin.

Opportunities

• Emerging Economies: There are significant opportunities for growth in emerging economies where the prevalence of type 2 diabetes is rapidly increasing. Improving healthcare infrastructure and increasing access to medications in these regions can drive market expansion[4].
• Research and Development: Ongoing research aimed at exploring novel uses, combination therapies, and new formulations of sitagliptin presents opportunities for market growth and innovation[4].

Financial Trajectory

The financial trajectory of the sitagliptin phosphate market is robust and promising. Here are some key financial highlights:

• Market Value: The market is expected to grow from USD 6.66 billion in 2024 to USD 60.09 billion by 2031, indicating a substantial increase in revenue over the forecast period[4].
• CAGR: The market is projected to grow at a CAGR of 34.90% from 2024 to 2031, which is one of the highest growth rates in the pharmaceutical industry[4].
• Revenue Projections: The comprehensive analysis of the market ensures that the revenue projections are based on a thorough segmentation of the market, including product pricing, market penetration, and competitive surroundings[1].

Cost-Effectiveness and Pharmacoeconomic Value

Studies have consistently shown that sitagliptin offers a high therapeutic effect with a satisfactory cost-effectiveness ratio. For instance, a study comparing sitagliptin with other antidiabetic medications found that sitagliptin had a lower cost-effectiveness ratio and higher therapeutic efficacy, making it a cost-effective option for long-term treatment[2].

"The application of Sitagliptin in the treatment of diabetic patients can effectively enhance the therapeutic effect. The cost effectiveness is satisfactory, and the blood glucose level can be maintained at a stable state."[2]

Competitive Landscape

The competitive landscape of the sitagliptin market includes several key players and a range of antidiabetic medications. While sitagliptin remains a dominant player, other medications like liraglutide are gaining traction due to their efficacy profiles. However, sitagliptin's established market presence and favorable pharmacoeconomic profile continue to support its market position[5].

Regional Analysis

The Asia-Pacific region is leading the global sitagliptin market, driven by the growing prevalence of type 2 diabetes in countries like China, India, and Japan. This region's expanding healthcare infrastructure and rising awareness about diabetes management are key factors contributing to the market's growth[4].

Key Takeaways

• Rapid Market Growth: The sitagliptin phosphate market is expected to grow significantly, driven by the rising prevalence of type 2 diabetes and a focus on diabetes management.
• High CAGR: The market is projected to grow at a CAGR of 34.90% from 2024 to 2031.
• Cost-Effectiveness: Sitagliptin offers a satisfactory cost-effectiveness ratio, making it a preferred choice for long-term treatment.
• Emerging Economies: There are significant opportunities for growth in emerging economies with improving healthcare infrastructure and increasing access to medications.
• Research and Development: Ongoing research aimed at exploring novel uses and new formulations of sitagliptin presents opportunities for market growth and innovation.

FAQs

What is the projected market size of the sitagliptin phosphate market by 2031?

The sitagliptin market is projected to reach USD 60.09 billion by 2031[4].

What is the CAGR of the sitagliptin phosphate market from 2024 to 2031?

The market is projected to grow at a CAGR of 34.90% from 2024 to 2031[4].

What are the main drivers of the sitagliptin phosphate market?

The main drivers include the rising prevalence of type 2 diabetes, a focus on diabetes management, and a favorable regulatory environment[4].

Which region is leading the global sitagliptin market?

The Asia-Pacific region, particularly countries like China, India, and Japan, is leading the global sitagliptin market[4].

Is sitagliptin cost-effective compared to other antidiabetic medications?

Yes, sitagliptin has been shown to offer a satisfactory cost-effectiveness ratio compared to other antidiabetic medications[2].

Sources

1. Market Research Intellect: Sitagliptin Phosphate API Market Size, Scope And Forecast Report.
2. PubMed: Analysis of pharmacoeconomic value of sitagliptin in the treatment of diabetic patients.
3. Clarivate: JANUVIA®.
4. Verified Market Research: Sitagliptin Market Size, Share, Scope, Trends, Analysis & Forecast.
5. PubMed: Incremental cost-effectiveness ratios (ICERs) were generated for liraglutide 1.2 mg compared with sitagliptin and liraglutide 1.8 mg compared with sitagliptin.