Zydus Lifesciences has secured final approval from the US Food and Drug Administration (USFDA) for its generic Ascorbic Acid Injection, according to a CNBC-TV18 report. The product is eligible for potential 180-day exclusivity, and the reference market for the drug in the United States is valued at approximately $11.6 million annually.

Ascorbic acid, widely known as vitamin C, is an essential water-soluble nutrient. Injectable formulations of ascorbic acid are used to treat vitamin C deficiency, including scurvy, particularly in patients who require supplementation but cannot take the vitamin orally. While scurvy is rare in modern clinical practice, it can still occur in people with severely restricted diets or conditions that impair nutrient absorption.

Under the US generic drug framework established by the Hatch-Waxman Act, 180-day exclusivity can be granted to the first applicant to file an abbreviated new drug application (ANDA) containing a patent challenge for a specific drug. During the exclusivity period, the FDA generally may not approve competing generic versions of the same drug, effectively granting the holder a temporary monopoly on the US generic market for that product. When multiple applicants tie as first filers, the exclusivity window is shared among them, which is one reason companies typically describe such exclusivity as potential rather than guaranteed.

A final USFDA approval, as opposed to a tentative approval, permits a manufacturer to market and commercially launch the approved product in the United States. Tentative approvals are issued when an application otherwise meets the FDA's requirements but existing patents or exclusivities still block a launch, forcing the applicant to wait before it can begin selling.

Zydus Lifesciences, formerly known as Cadila Healthcare, is an India-headquartered global pharmaceutical company based in Ahmedabad, Gujarat. The company operates across generics, specialty medicines, and other therapeutic segments, with the United States ranking among its key formulations markets. Indian drugmakers such as Zydus are major suppliers to the US generic market, where lower-cost copies of branded drugs account for the large majority of prescriptions filled, and individual USFDA approvals are disclosed routinely as companies accumulate approved products in their US portfolios. Its shares are listed on Indian stock exchanges.

Source: CNBC-TV18