We can launch a new drug every 2 or 3 years, Wockhardt chairman Khorakiwala

Wockhardt chairman Habil Khorakiwala. (file photo)

• Wockhardt plans to launch 5–6 new antibiotics in the next 4–5 years
• Zaynich antibiotic under USFDA Fast Track review, approval likely by mid-2026.
• Company aims to focus exclusively on antibiotics for the next 10–20 years

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Drugmaker Wockhardt expects the next decade to be a defining phase for its innovation strategy, with the company preparing to roll out a steady stream of novel antibiotics to tackle drug resistance, a growing are of concern among doctors and patients alike.

Chairman Dr Habil Khorakiwala has told Moneycontrol that Wockhardt has five to six new drugs slated for launch over the next four to five years and has more in early stages of development.

"So, we will have every two years, three years, a new drug coming out for the next 10 to 15 years. I have another two or three drugs which we have not even announced, which are in early stages," he said on the sidelines of an industry event in Mumbai recently.

The portfolio, internally referred to as the “next wave of pipeline assets”, stays firmly anchored in antibiotics, an area big pharma has abandoned due to low commercial returns.

Wockhardt chose a “white‑space strategy” in anti‑infectives, where global players have pulled back and resistance levels are rising sharply, creating both medical need and market opportunity, Khorakiwala said.

“Why would we give up a lead we already have?” he said, adding Wockhardt plans to remain exclusively focused on antibiotics for the next 10–20 years.

Wockhardt's antibiotic pipeline is focused heavily on multi-drug resistant (MDR) infections, with novel agents such as Zaynich (Zidebactam/Cefepime) currently seeking USFDA approval. WCK 6777 (Odrate), a once-daily outpatient treatment for complex infections such as those of the urinary tract and intra-abdominal, has received USFDA Fast Track designation.

The company also has early-stage candidates such as WCK 771 and WCK 2349, and the recently launched Indian respiratory antibiotic Miqnaf (Nafithromycin), all targeting critical unmet needs for severe bacterial infections.

The company also has WCK 4282, branded as Foviscu, undergoing clinical trials.

Zaynich’s review status

Khorakiwala said Zaynich’s new drug application (NDA) is under a six–to eight–month Fast Track USFDA review, with expected approval by mid‑2026, and he is “very confident of a positive outcome” for the drug aimed at life-threatening multi-drug resistant “superbugs”.

Khorakiwala said the company is evaluating various strategies to take its pipeline global: building its own commercial footprint in markets such as the US for injectable hospital antibiotics, and selectively pursuing partnerships or licensing deals if the economics justify it.

Wockhardt has appointed a merchant banker and is holding discussions with potential partners, though Khorakiwala insists the company will commercialise products independently if valuations do not reflect the scientific value created.

Developing a commercial organisation is “far easier” than building a research engine, particularly since the company’s new drugs are aimed at tertiary-care, high-end hospitals that require focused sales teams of “50–100 people” in the US market, Khorakiwala said.

He also positioned Wockhardt’s antibiotic research as a strategic national asset, saying India could become a global leader if the government directs funding and regulatory reforms toward organisations with demonstrated innovation capability. The company has called for streamlining Phase 3 approvals, which take nearly two years in India compared to five to six months in the US and Europe.