SIMVASTATIN; SITAGLIPTIN PHOSPHATE - Generic Drug Details

What are the generic sources for simvastatin; sitagliptin phosphate and what is the scope of patent protection?

Simvastatin; 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 three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Simvastatin; sitagliptin phosphate has fifty-two patent family members in forty countries.

Summary for SIMVASTATIN; SITAGLIPTIN PHOSPHATE

International Patents:	52
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMVASTATIN; SITAGLIPTIN PHOSPHATE
DailyMed Link:	SIMVASTATIN; SITAGLIPTIN PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SIMVASTATIN; 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.

Anatomical Therapeutic Chemical (ATC) Classes for SIMVASTATIN; 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

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	202343	1	2012-11-06
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/20 mg	202343	1	2012-06-25
JUVISYNC	Tablets	simvastatin; sitagliptin phosphate	100 mg/10 mg and 100 mg/40 mg	202343	1	2012-06-19

US Patents and Regulatory Information for SIMVASTATIN; 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	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-003	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y

Expired US Patents for SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	7,459,428
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011	8,168,637
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	6,890,898
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	6,890,898
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	8,168,637
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-005	Sep 18, 2012	7,459,428
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012	8,168,637

International Patents for SIMVASTATIN; 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 SIMVASTATIN; SITAGLIPTIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402

SIMVASTATIN; SITAGLIPTIN PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Simvastatin and Sitagliptin Phosphate

Introduction to Simvastatin and Sitagliptin Phosphate

Simvastatin and sitagliptin phosphate are two widely used pharmaceuticals, each addressing different health concerns. Simvastatin is a statin used to lower cholesterol levels and prevent cardiovascular diseases, while sitagliptin phosphate is an antidiabetic medication used to manage type 2 diabetes.

Simvastatin Market Dynamics

Global Market Size and Growth Rate

The global Simvastatin drug market is projected to grow at a compound annual growth rate (CAGR) of 5.20% from 2023 to 2030. The market size was valued at USD XX billion in 2023 and is expected to expand significantly over the forecast period[1].

Regional Market Performance

• North America: This region commands the largest market share, with approximately 40% of the global market. The high prevalence of lifestyle-related diseases such as hypercholesterolemia and cardiovascular disorders in the United States drives the demand for Simvastatin. Robust healthcare infrastructure and advanced diagnostic capabilities also contribute to its widespread use[1].
• Asia Pacific: This region is the fastest-growing market for Simvastatin, with a CAGR of 6.6% from 2023 to 2030. Rising awareness about heart health, lifestyle changes, and improving healthcare infrastructure are key drivers of this growth. The adult demographic, particularly those susceptible to cardiovascular conditions, is the primary segment fueling this growth[1].

Market Challenges

The expiration of Simvastatin's patent has led to the entry of numerous generic versions into the market. While this benefits consumers by making the drug more affordable, it poses significant challenges for original manufacturers in terms of revenue. The increased competition reduces profit margins and intensifies pricing pressures, making it challenging for innovator companies to maintain market share and sustain substantial profits[1].

Sitagliptin Phosphate Market Dynamics

Global Market Size and Growth Rate

The Sitagliptin Phosphate API market is anticipated to experience robust growth, with the global Sitagliptin market projected to reach USD 60.09 billion by 2031, growing at a CAGR of 34.90% from 2024 to 2031[5].

Regional Market Performance

• Asia Pacific: This region accounts for the most significant share of the global Sitagliptin market. The growing prevalence of type 2 diabetes in countries like China, India, and Japan, coupled with expanding healthcare infrastructure and rising awareness about diabetes management, drives the market growth in this region[5].

Market Drivers

The rapid expansion of the Sitagliptin market is primarily driven by the growing prevalence of type 2 diabetes, which leads to an increased demand for effective diabetes management solutions. Other key drivers include a growing focus on diabetes management, a favorable regulatory environment, and ongoing research and development efforts aimed at exploring novel uses and combination therapies for sitagliptin[5].

Market Opportunities

Emerging economies offer significant opportunities for growth, with rising healthcare expenditures, improving healthcare infrastructure, and increasing access to medications. Investigating new uses, combination therapies, and new formulations can drive innovation and further adoption of sitagliptin[5].

Financial Trajectory for Simvastatin

Revenue Projections

The global Simvastatin market is expected to grow steadily, driven by the ongoing demand for cholesterol management solutions. However, the financial trajectory is influenced by the competitive landscape, with generic versions impacting the revenue streams of original manufacturers. Despite this, the market is projected to maintain a CAGR of 5.20% from 2023 to 2030, indicating sustained growth albeit with reduced profit margins for innovator companies[1].

Regional Revenue Contributions

North America, being the largest market, contributes significantly to the overall revenue. The Asia Pacific region, with its rapid growth rate, is also expected to contribute substantially to the global revenue by 2030[1].

Financial Trajectory for Sitagliptin Phosphate

Revenue Projections

The Sitagliptin Phosphate API market is poised for significant financial growth, with the global market projected to reach USD 60.09 billion by 2031. This growth is driven by the increasing prevalence of type 2 diabetes and the growing demand for effective antidiabetic medications. The market's CAGR of 34.90% from 2024 to 2031 indicates a robust financial trajectory[5].

Regional Revenue Contributions

Asia Pacific is the leading region in terms of revenue contribution, driven by the high prevalence of type 2 diabetes and the expanding healthcare infrastructure in countries like China, India, and Japan[5].

Competitive Landscape

Simvastatin

The competitive landscape for Simvastatin is highly competitive due to the presence of multiple generic versions. This competition reduces the market share and profit margins of original manufacturers, making it challenging to sustain substantial profits. However, the ongoing demand for cholesterol management solutions ensures a steady market presence[1].

Sitagliptin Phosphate

The Sitagliptin Phosphate market benefits from a favorable competitive landscape, driven by the growing demand for antidiabetic medications. The market's robust growth rate and the absence of significant generic competition during the forecast period contribute to its attractive financial trajectory. Ongoing research and development efforts also enhance the market's competitive position[5].

Key Takeaways

• Simvastatin Market: Expected to grow at a CAGR of 5.20% from 2023 to 2030, driven by demand for cholesterol management solutions, despite challenges from generic versions.
• Sitagliptin Phosphate Market: Projected to grow at a CAGR of 34.90% from 2024 to 2031, driven by the increasing prevalence of type 2 diabetes and favorable market conditions.
• Regional Performance: North America and Asia Pacific are key regions for both markets, with Asia Pacific showing the most significant growth for both Simvastatin and Sitagliptin Phosphate.
• Market Drivers and Challenges: Simvastatin faces challenges from generic competition, while Sitagliptin Phosphate benefits from growing demand for diabetes management solutions.

FAQs

Q: What is the projected CAGR for the global Simvastatin market from 2023 to 2030?

A: The global Simvastatin market is projected to grow at a CAGR of 5.20% from 2023 to 2030[1].

Q: Which region is the fastest-growing market for Simvastatin?

A: The Asia Pacific region is the fastest-growing market for Simvastatin, with a CAGR of 6.6% from 2023 to 2030[1].

Q: What drives the growth of the Sitagliptin Phosphate market?

A: The growth of the Sitagliptin Phosphate market is driven by the increasing prevalence of type 2 diabetes, a growing focus on diabetes management, and a favorable regulatory environment[5].

Q: What is the projected market size for Sitagliptin Phosphate by 2031?

A: The global Sitagliptin market is projected to reach USD 60.09 billion by 2031, growing at a CAGR of 34.90% from 2024 to 2031[5].

Q: How does the competitive landscape affect the financial trajectory of Simvastatin and Sitagliptin Phosphate?

A: The competitive landscape for Simvastatin is highly competitive due to generic versions, reducing profit margins. In contrast, the Sitagliptin Phosphate market benefits from a favorable competitive landscape with significant growth potential[1][5].

Sources

1. Cognitive Market Research, "Simvastatin Drug Market Report 2024 (Global Edition)".
2. Market Research Intellect, "Sitagliptin Phosphate API Market Size, Scope And Forecast Report".
3. ACE Sphere, "Announcement: MAYANK VERMA - ACE SPHERE".
4. Market Research Intellect, "Ezetimibe and Simvastatin Sales Market Size, Scope And Forecast Report".
5. Verified Market Research, "Sitagliptin Market Size, Share, Scope, Trends, Analysis & Forecast".