INDIA — Glenmark Pharmaceuticals has launched a triple-drug fixed-dose combination (FDC) in India, known as Zita DM.
This innovative FDC combines Teneligliptin (20mg), Dapagliflozin (10mg), and Metformin SR (500mg/1000mg) in a single daily prescription.
The primary objective of Zita DM is to enhance glycemic control in adult patients with Type 2 diabetes, particularly those dealing with additional health issues.
Alok Malik, President & Business Head ‐ India Formulations at Glenmark Pharma, underscored the significance of this development in a country with the world’s second-largest diabetic population.
Patients with Type 2 diabetes in India often grapple with uncontrolled Hemoglobin A1C (HbA1Ci) and other comorbidities, making diabetes management a complex challenge.
The launch of Zita DM aims to address these concerns and facilitate adherence to chronic diabetes treatments.
Glenmark Pharmaceuticals is the pioneer in introducing this triple-drug combination for Type 2 diabetes in India. Zita DM is not only a novel anti-diabetic medication but also an affordable one.
The pricing of Zita DM, at Rs 14 (US$0.17) per tablet, is expected to reduce the daily therapy cost by 30%, making it more accessible to a broader patient base.
It offers improved glycemic control for adults with high HbA1c levels and comorbidities while reducing the risk of major renal and cardiac adverse events.
Glenmark’s Zita portfolio of medicines has been benefiting approximately 1.75 million Type 2 diabetic patients in India annually.
The introduction of Zita DM further enhances the comprehensive gliptin range of Zita, promising support for Type 2 diabetic patients at every stage of their treatment.
The product launch aligns with the growth in the market for oral anti-diabetic drugs in India, which, according to IQVIA sales data, reached an estimated value of Rs 12,522 crore (US$1.5 billion), showing an annual increase of 6.5% compared to the previous year.
Judge OKs US$70M settlement in Merck & Glenmark class-action suit
In another legal development, a federal judge has approved a US$70 million settlement in a class-action lawsuit involving Merck & Co Inc. and Glenmark Pharmaceuticals.
The lawsuit alleged collusion between the two companies to delay the launch of a generic version of Merck’s anti-cholesterol drug, Zetia. This settlement brings a five-year antitrust litigation to a close.
The plaintiffs in this case, including municipal employee benefit funds, claimed that the two drugmakers violated antitrust laws by entering into a settlement in 2010.
In this settlement, Merck dropped patent infringement claims over Glenmark’s proposed generic version of Zetia, and Glenmark agreed not to launch its version for nearly five years.
The plaintiffs argued that, had it not been for this settlement, Glenmark would have successfully launched a generic Zetia earlier.
Merck agreed not to launch its own authorized generic version of Zetia, a concession worth US$800 million, which is a common practice known as a “pay for delay” deal.
Additionally, Glenmark Pharmaceuticals recently divested a 75% stake in its division, Glenmark Life Sciences (GLS), to Indian company Nirma.
This deal, valued at Rs56.51 billion (US$679.85 million), focuses on the production of active pharmaceutical ingredients (API). Glenmark Pharma will retain a 7.84% stake in GLS following the divestiture.
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