Zydus announces agreement with CVS Caremark to add Zituvio™, Zituvimet™ and Zituvimet™ XR (Sitagliptin | Sitagliptin and Metformin Hydrochloride) to its template formulary

Rhea-AI Summary

Zydus Lifesciences has announced an agreement with CVS Caremark to include its diabetes medications Zituvio™, Zituvimet™, and Zituvimet™ XR in CVS's template formulary starting January 1, 2025. These products, containing sitagliptin and metformin hydrochloride, are approved by the FDA through the 505(b)(2) route for improving glycemic control in adults with type 2 diabetes mellitus.

The medications work through DPP-4 inhibition and as biguanides, serving as an adjunct to diet and exercise. According to IQVIA™ data (MAT Aug-2023), the U.S. market for DPP-IV inhibitors and their combinations is valued at US$ 10 billion. This partnership represents a significant opportunity for Zydus to expand its presence in the U.S. market with its differentiated product portfolio.

Positive

• Access to CVS Caremark's large customer base through formulary inclusion
• Entry into $10 billion U.S. market for DPP-IV inhibitors
• Strategic expansion of 505(b)(2) portfolio in U.S. market

Negative

• None.

Insights

Pharmaceutical Market Analyst

The addition of Zydus's Sitagliptin products to CVS Caremark's formulary represents a substantial market opportunity in the $10 billion DPP-IV inhibitor space. This strategic placement will enable Zydus to capture market share from Merck's Januvia/Janumet franchise, which has historically dominated this segment. The timing is particularly advantageous as patents expire and healthcare providers seek cost-effective alternatives.

The formulary inclusion significantly enhances Zydus's market penetration potential, considering CVS Caremark manages prescriptions for approximately 110% of Americans. The 505(b)(2) pathway chosen by Zydus demonstrates a smart regulatory strategy, balancing speed to market with development costs while maintaining therapeutic equivalence to reference products.

For CVS Health, this agreement aligns with their strategy to reduce healthcare costs while maintaining quality care, potentially improving their competitive position in the PBM space and supporting profitability in their healthcare benefits segment.

Healthcare Economics Expert

This formulary addition carries significant economic implications for both entities. For CVS, it strengthens their negotiating position with other manufacturers and potentially reduces costs in their diabetes care portfolio. The timing coincides with increasing pressure to lower healthcare costs, particularly in diabetes management where costs have risen substantially.

The $10 billion market size indicates substantial revenue potential, with even a modest market share capture representing meaningful earnings. The agreement's implementation on January 1, 2025, strategically aligns with most insurance plan renewal cycles, maximizing potential adoption.

For investors, this signals CVS's continued commitment to cost management and vertical integration strategy, potentially improving margins in their PBM business while maintaining competitive positioning in the healthcare benefits segment.

AHMEDABAD, India, Jan. 7, 2025 /PRNewswire/ -- Zydus Lifesciences Ltd. (including its subsidiaries/affiliates, hereafter referred to as 'Zydus'), a global innovation driven healthcare company announced that it has entered into an agreement with CVS Caremark^®, a CVS Health^® (NYSE: CVS) company to add Zituvio™, Zituvimet™ and Zituvimet™ XR (Sitagliptin | Sitagliptin and Metformin Hydrochloride) tablets to its template formulary.

CVS Caremark will add Zydus' Zituvio™ and combination products to its template formulary starting January 1, 2025.

Zituvio and combination products include Zituvio™ (sitagliptin), Zituvimet™ (sitagliptin and metformin hydrochloride) and Zituvimet™ XR (sitagliptin and metformin hydrochloride) extended-release tablets. These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route. The Zituvio range of products contain active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Punit Patel, President & CEO Zydus Pharmaceuticals USA Inc., commented on the development, saying, "We are proud to have partnered with CVS Caremark, one of the most patient-centric healthcare solutions providers in the US, to further our commitment to improving access to high-quality medications to patients and meeting their healthcare needs with reduced outlays. This relationship is a strong validation of Zydus' strategic investments in 505(b)(2) portfolio and will set the way for further strengthening our portfolio of differentiated products in the US market."

Metabolic and lifestyle conditions, such as diabetes have been a significant contributor to prescription drug growth over the last decade.

According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and their combinations is US$ 10 bn.

About Zydus

Zydus Lifesciences Ltd., with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com.

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SOURCE Zydus Lifesciences Limited

FAQ

When will CVS Caremark add Zydus's Zituvio products to its formulary?

CVS Caremark will add Zydus's Zituvio products to its template formulary starting January 1, 2025.

What is the current market size for DPP-IV inhibitors in the US where CVS will distribute Zituvio?

According to IQVIA™ data (MAT Aug-2023), the U.S. market for DPP-IV inhibitors and their combinations is US$ 10 billion.

What medical conditions do the Zituvio products added to CVS formulary treat?

The Zituvio range of products are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What are the active ingredients in the Zituvio products being added to CVS formulary?

The products contain sitagliptin (a DPP-4 inhibitor) and metformin hydrochloride (a biguanide), either alone or in combination.