ZITUVIMET Drug Patent Profile

Which patents cover Zituvimet, and what generic alternatives are available?

Zituvimet is a drug marketed by Zydus Lifesciences and is included in two NDAs.

The generic ingredient in ZITUVIMET is metformin hydrochloride; sitagliptin. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin profile page.

Summary for ZITUVIMET

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in ZITUVIMET?	ZITUVIMET excipients list
DailyMed Link:	ZITUVIMET at DailyMed

Pharmacology for ZITUVIMET

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

US Patents and Regulatory Information for ZITUVIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	ZITUVIMET	metformin hydrochloride; sitagliptin	TABLET;ORAL	216743-002	Nov 3, 2023		RX	Yes	Yes
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778-003	Jul 18, 2024		RX	Yes	Yes
Zydus Lifesciences	ZITUVIMET	metformin hydrochloride; sitagliptin	TABLET;ORAL	216743-001	Nov 3, 2023		RX	Yes	No
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778-002	Jul 18, 2024		RX	Yes	No
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778-001	Jul 18, 2024		RX	Yes	No

EU/EMA Drug Approvals for ZITUVIMET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Ristfor	sitagliptin, metformin hydrochloride	EMEA/H/C/001235 For patients with type-2 diabetes mellitus:Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	no	no	no	2010-03-15
Accord Healthcare S.L.U.	Sitagliptin / Metformin hydrochloride Accord	sitagliptin, metformin hydrochloride	EMEA/H/C/005850 For adult patients with type 2 diabetes mellitus:It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	yes	no	no	2022-07-22
Sun Pharmaceutical Industries Europe B.V.	Sitagliptin / Metformin hydrochloride Sun	sitagliptin, metformin hydrochloride	EMEA/H/C/005778 For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	yes	no	no	2023-03-31

ZITUVIMET Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Zituvimet

Introduction to Zituvimet

Zituvimet, a recent addition to the pharmaceutical portfolio of Zydus Lifesciences, is a combination drug designed to improve glycemic control in adults with type 2 diabetes mellitus. The drug combines sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, making it a potent adjunct to diet and exercise for managing type 2 diabetes[1][4].

Regulatory Approval and Compliance

Zituvimet received final approval from the United States Food and Drug Administration (USFDA) in November 2023. This approval was granted after rigorous quality testing for Nitrosamines and potential genotoxic impurities, ensuring compliance with current USFDA standards[1][4].

Market Context: Type 2 Diabetes Treatment

The US market for DPP-IV inhibitors and their combinations is substantial, valued at $10 billion as of August 2023, according to IQVIA data. This market size indicates a significant demand for effective and affordable treatments for type 2 diabetes, positioning Zituvimet favorably[1][4].

Competitive Landscape

The generic drug industry is characterized by intense competition, with prices decreasing as the number of competitors increases. However, prices remain above long-run marginal costs until there are at least 8 competitors in the market. Zituvimet's entry into this market is expected to increase competition, potentially driving down prices and improving affordability for healthcare systems[3].

Financial Impact on Zydus Lifesciences

The approval of Zituvimet is part of Zydus Lifesciences' broader strategy to enhance its financial performance. Here are some key financial highlights:

Consolidated Revenues

Zydus Lifesciences reported a 13% year-over-year increase in consolidated revenues for FY 2024, reaching INR 195.5 billion. This growth is partly attributed to the expansion of its product portfolio, including the addition of Zituvimet[2].

EBITDA Margin and Net Profit

The company's EBITDA margin improved significantly to 27.5%, a 510 basis points increase from the previous year, resulting in a 40% growth in consolidated EBITDA to INR 53.8 billion. Net profit also saw a substantial jump, up 97% to INR 38.6 billion[2].

Quarterly Performance

In the fourth quarter of FY 2024, Zydus Lifesciences recorded robust growth with revenues of INR 55.3 billion, up 10% year-over-year and 23% quarter-over-quarter. The EBITDA margin for the quarter was 29.5%, with EBITDA standing at INR 16.3 billion, up 30% year-over-year and 48% sequentially. Net profit for the quarter was INR 11.8 billion, up 299% year-over-year and 50% sequentially[2].

Balance Sheet Strength

Zydus Lifesciences has strengthened its balance sheet, with a net cash position of INR 8.6 billion as of March 31, 2024, up from INR 5.5 billion the previous year. This financial health positions the company well to invest in research, development, and market expansion, including the promotion of Zituvimet[2].

Affordability and Accessibility

The approval of Zituvimet is expected to provide an affordable treatment option for healthcare systems, helping to reduce the rate of growth in drug spending and improving the financial sustainability of healthcare programs. As stated by Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, "The Zituvimet approval further builds on our previous approval of Zituvimet (Sitagliptin) and offers increased accessibility and affordability to healthcare systems with regard to prescription drugs for type II diabetes"[1][4].

Research and Development

Zydus Lifesciences has a robust research and development infrastructure, with facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim. The company's ability to conduct thorough research and regulatory work has been instrumental in securing the USFDA approval for Zituvimet[1].

Recent Acquisitions and Expansions

In addition to the approval of Zituvimet, Zydus Lifesciences has been expanding its footprint through strategic acquisitions. For instance, the company acquired UK-based LiqMeds Group for around Rs 689 crore, further enhancing its capabilities and market reach[4].

Emerging Markets and Europe Formulations

Zydus Lifesciences has seen robust growth momentum in emerging markets and Europe, with its formulations business delivering healthy double-digit growth. This growth is expected to continue, supported by the launch of new products like Zituvimet[5].

Injectable and Transdermal Business

The company's injectable business is outperforming expectations, and upcoming transdermal launches are projected to generate significant revenue, estimated between $50-60 million. This diversification in product offerings is crucial for maintaining a strong financial trajectory[5].

Key Takeaways

• Regulatory Approval: Zituvimet received USFDA approval in November 2023, ensuring compliance with current FDA standards.
• Market Size: The US market for DPP-IV inhibitors and combinations is valued at $10 billion.
• Financial Performance: Zydus Lifesciences reported a 13% increase in consolidated revenues and a 97% increase in net profit for FY 2024.
• Affordability: Zituvimet aims to provide an affordable treatment option, reducing drug spending growth and enhancing healthcare program sustainability.
• Research and Development: Strong R&D infrastructure supported the approval and will continue to drive innovation.
• Expansions: Strategic acquisitions and expansions, such as the LiqMeds Group, are enhancing the company's capabilities.

FAQs

Q: What is Zituvimet and how is it used? A: Zituvimet is a combination drug containing sitagliptin and metformin hydrochloride, used to improve glycemic control in adults with type 2 diabetes mellitus.

Q: What is the significance of the USFDA approval for Zituvimet? A: The USFDA approval ensures that Zituvimet meets current FDA standards for quality and safety, including testing for Nitrosamines and potential genotoxic impurities.

Q: How does Zituvimet impact the financial performance of Zydus Lifesciences? A: The approval of Zituvimet contributes to the company's overall revenue growth and profitability, aligning with its strategy to enhance financial performance through product expansion.

Q: What is the market size for DPP-IV inhibitors and their combinations in the US? A: The US market for DPP-IV inhibitors and their combinations is valued at $10 billion as of August 2023.

Q: How does Zituvimet affect healthcare systems in terms of affordability? A: Zituvimet is designed to provide an affordable treatment option, helping to reduce the rate of growth in drug spending and improve the financial sustainability of healthcare programs.

Cited Sources

1. CNBC TV18: "Zydus Lifesciences gets USFDA nod for drug used for treatment of type 2 diabetes mellitus patients"[1]
2. Alpha Spread: "ZYDUSLIFE Q4-2024 Earnings Call"[2]
3. Federal Trade Commission: "Generic Drug Industry Dynamics"[3]
4. Business Standard: "Zydus gets USFDA nod for Zituvimet for type-2 diabetes mellitus treatment"[4]
5. Alpha Spread: "ZYDUSLIFE Q3-2024 Earnings Call"[5]