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

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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.

Zydus Lifesciences ha annunciato un accordo con CVS Caremark per includere i suoi farmaci per il diabete Zituvio™, Zituvimet™ e Zituvimet™ XR nel formulare standard di CVS a partire dal 1 gennaio 2025. Questi prodotti, contenenti sitagliptin e metformina cloridrato, sono stati approvati dalla FDA attraverso il percorso 505(b)(2) per migliorare il controllo glicemico negli adulti con diabete di tipo 2.

I farmaci agiscono mediante inibizione della DPP-4 e come biguanidi, fungendo da complemento a dieta ed esercizio fisico. Secondo i dati di IQVIA™ (MAT Ago-2023), il mercato statunitense per gli inibitori della DPP-IV e le loro combinazioni è valutato 10 miliardi di dollari statunitensi. Questa partnership rappresenta un'opportunità significativa per Zydus di espandere la propria presenza nel mercato statunitense con il suo portafoglio di prodotti differenziato.

Zydus Lifesciences ha anunciado un acuerdo con CVS Caremark para incluir sus medicamentos para la diabetes Zituvio™, Zituvimet™ y Zituvimet™ XR en el formulario estándar de CVS a partir del 1 de enero de 2025. Estos productos, que contienen sitagliptina y metformina hidrocloruro, han sido aprobados por la FDA a través de la vía 505(b)(2) para mejorar el control glucémico en adultos con diabetes tipo 2.

Los medicamentos funcionan a través de la inhibición de DPP-4 y como biguanidas, sirviendo como complemento a la dieta y el ejercicio. Según los datos de IQVIA™ (MAT Ago-2023), el mercado estadounidense para los inhibidores de DPP-IV y sus combinaciones está valorado en 10 mil millones de dólares estadounidenses. Esta asociación representa una oportunidad significativa para Zydus para expandir su presencia en el mercado de EE. UU. con su portafolio de productos diferenciados.

Zydus LifesciencesCVS Caremark과의 협약을 발표하고, 2025년 1월 1일부터 CVS의 표준 처방 목록에 당뇨병 약제 Zituvio™, Zituvimet™ 및 Zituvimet™ XR을 포함하기로 했습니다. 이 제품들은 사타글립틴과 메트포르민 염산염을 포함하고 있으며, 제2형 당뇨병 성인에서 혈당 조절을 개선하기 위해 FDA에서 505(b)(2) 경로로 승인받았습니다.

이 약물은 DPP-4 억제 작용과 빅구아이드로 작용하여, 식이요법과 운동의 보조제로 작용합니다. IQVIA™ 데이터(2023년 8월 기준)에 따르면, DPP-IV 억제제 및 이들의 조합을 위한 미국 시장 가치는 100억 달러입니다. 이번 파트너십은 Zydus가 차별화된 제품 포트폴리오로 미국 시장에서 입지를 확장할 수 있는 중요한 기회를 제공합니다.

Zydus Lifesciences a annoncé un accord avec CVS Caremark pour inclure ses médicaments contre le diabète Zituvio™, Zituvimet™ et Zituvimet™ XR dans le formulaire standard de CVS à partir du 1er janvier 2025. Ces produits, contenant du sitagliptin et du chlorhydrate de metformine, ont été approuvés par la FDA via la voie 505(b)(2) pour améliorer le contrôle glycémique chez les adultes atteints de diabète de type 2.

Les médicaments agissent par inhibition de DPP-4 et comme biguanides, servant de complément à un régime alimentaire et à de l'exercice. Selon les données d'IQVIA™ (MAT août 2023), le marché américain des inhibiteurs de DPP-IV et de leurs combinaisons est estimé à 10 milliards de dollars américains. Ce partenariat représente une opportunité significative pour Zydus d'étendre sa présence sur le marché américain avec son portefeuille de produits différenciés.

Zydus Lifesciences hat eine Vereinbarung mit CVS Caremark bekannt gegeben, um seine Diabetesmedikamente Zituvio™, Zituvimet™ und Zituvimet™ XR ab dem 1. Januar 2025 in das Standardformular von CVS aufzunehmen. Diese Produkte, welche Sitagliptin und Metforminhydrochlorid enthalten, wurden von der FDA über den 505(b)(2)-Weg zur Verbesserung der glykämischen Kontrolle bei Erwachsenen mit Typ-2-Diabetes mellitus genehmigt.

Die Medikamente wirken durch DPP-4-Hemmung und als Biguanide und dienen als Ergänzung zu Diät und Bewegung. Laut IQVIA™-Daten (MAT August 2023) wird der US-Markt für DPP-IV-Hemmer und deren Kombinationen auf 10 Milliarden US-Dollar geschätzt. Diese Partnerschaft stellt für Zydus eine bedeutende Gelegenheit dar, seine Präsenz auf dem US-Markt mit seinem differenzierten Produktportfolio auszubauen.

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

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.

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.

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