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zituvio Drug Patent Profile

When do Zituvio patents expire, and what generic alternatives are available?

Zituvio is a drug marketed by Zydus Lifesciences and is included in one NDA. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in ZITUVIO is sitagliptin. There are thirty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sitagliptin profile page.

DrugPatentWatch^® Generic Entry Outlook for Zituvio

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2035. This may change due to patent challenges or generic licensing.

There are seventeen tentative approvals for the generic drug (sitagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for zituvio

International Patents:	4
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for zituvio
What excipients (inactive ingredients) are in zituvio?	zituvio excipients list
DailyMed Link:	zituvio at DailyMed

See drug prices for zituvio

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

NDA:

211566

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.

Pharmacology for zituvio

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

US Patents and Regulatory Information for zituvio

zituvio is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	211566-001	Oct 18, 2023		RX	Yes	No			Y
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-002	Oct 18, 2023		RX	Yes	No			Y
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566-003	Oct 18, 2023		RX	Yes	Yes			Y

EU/EMA Drug Approvals for zituvio

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 zituvio

See the table below for patents covering zituvio around the world.

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

Supplementary Protection Certificates for zituvio

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	42/2007	Austria		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
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
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321

Zituvio Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZITUVIO™

Introduction to ZITUVIO™

ZITUVIO™, developed by Zydus Lifesciences Limited, is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults. The drug contains the active ingredient Sitagliptin and is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control[1][4].

Market Context: DPP-4 Inhibitors

The U.S. market for DPP-IV inhibitors and their combinations is substantial, valued at approximately $10 billion as of August 2023, according to IQVIA™. This market size indicates a significant demand for treatments like ZITUVIO™, which targets a prevalent condition such as type 2 diabetes mellitus[1][4].

Competitive Landscape

The generic drug industry, including DPP-4 inhibitors, is characterized by intense competition. Research suggests that generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors in the market. This dynamic implies that early entrants into the market, such as Zydus with ZITUVIO™, can capture a significant market share and profits before prices drop due to increased competition[3].

Regulatory Approval and Compliance

ZITUVIO™ has undergone rigorous testing for Nitrosamines and potential genotoxic impurities, ensuring compliance with current USFDA standards. This regulatory approval is a critical milestone, reflecting Zydus' commitment to quality and safety in its products[1][4].

Dosage and Administration

The recommended dosage of ZITUVIO™ is 100 mg orally once daily, which can be taken with or without food. Dosage adjustments are recommended for patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m². This straightforward dosing regimen can enhance patient compliance and simplify treatment management[1][4].

Financial Performance of Zydus Lifesciences

Zydus Lifesciences has demonstrated robust financial performance in recent years. For FY 2024, the company reported a 13% year-over-year increase in consolidated revenues, reaching INR 195.5 billion. The EBITDA margin improved significantly to 27.5%, and the net profit saw a substantial jump of 97% to INR 38.6 billion. This strong financial trajectory is expected to continue, with projections of high teens growth in FY 2025 and maintenance of the current EBITDA margin[2].

Segment Performance: U.S. Formulations

The U.S. Formulations business of Zydus Lifesciences has been a key driver of growth. In Q4 2024, this segment accounted for 47% of the consolidated revenues, with a robust 37% sequential growth. The business has continued to expand through volume growth and new product launches, including ZITUVIO™, which is expected to contribute significantly to the company's revenue and profitability[2].

Impact on Chronic Portfolio

Zydus Lifesciences has seen a consistent increase in the contribution of its chronic portfolio, which includes antidiabetic therapies like ZITUVIO™. As of March 2024, the chronic portfolio accounted for 41.2% of the company's revenues, an improvement of 360 basis points over the last three years. This growth underscores the market demand for chronic care medications and Zydus' strategic focus on this segment[2].

Consumer Wellness and Other Segments

In addition to its formulations business, Zydus Lifesciences has a strong consumer wellness segment, which includes brands like Nycil and EverYuth. This segment recorded revenues of INR 7.8 billion in Q4 2024, up 10% year-over-year. The company's diversified portfolio helps mitigate risks and ensures sustained growth across various market segments[2].

Future Outlook

Zydus Lifesciences is poised for continued growth with a robust pipeline of over 30 product launches planned for FY 2025. The company's commitment to innovation and its ability to bring affordable medicines to the market are key factors in its success. With ZITUVIO™, Zydus aims to capture a significant share of the DPP-4 inhibitor market, contributing to its overall financial performance and market dominance[2].

Key Takeaways

• Market Size: The U.S. market for DPP-IV inhibitors is valued at $10 billion.
• Regulatory Approval: ZITUVIO™ has received FDA approval and complies with USFDA standards.
• Financial Performance: Zydus Lifesciences reported strong financial results for FY 2024, with a 13% increase in revenues and a 97% increase in net profit.
• Segment Growth: The U.S. Formulations business, including ZITUVIO™, has driven significant growth for Zydus.
• Future Outlook: Zydus plans over 30 product launches for FY 2025, ensuring continued growth and market expansion.

FAQs

Q: What is ZITUVIO™ used for? A: ZITUVIO™ is used to treat type 2 diabetes mellitus in adults as an adjunct to diet and exercise.

Q: What is the recommended dosage of ZITUVIO™? A: The recommended dosage is 100 mg orally once daily, which can be taken with or without food.

Q: How does ZITUVIO™ fit into Zydus Lifesciences' financial strategy? A: ZITUVIO™ is part of Zydus' chronic portfolio, which has seen significant growth and is expected to contribute to the company's revenue and profitability.

Q: What is the current market size for DPP-IV inhibitors in the U.S.? A: The U.S. market for DPP-IV inhibitors and their combinations is approximately $10 billion as of August 2023.

Q: How does competition affect the pricing of generic drugs like ZITUVIO™? A: Generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors in the market[3].

Cited Sources

1. Biospace: Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus.
2. Alpha Spread: ZYDUSLIFE Q4-2024 Earnings Call.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. PR Newswire: Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus.