Wockhardt’s $800-million bet on antibiotic research paid off on Saturday with the US drug regulator’s approval for Zaynich, only the second homegrown new drug from India to achieve the feat, and the first without a foreign partner. The company’s next task is converting that scientific breakthrough into commercial success.
The nod for Zaynich—an antibiotic for treatment of complicated urinary tract infection (UTI)—vindicates chairman and founder Habil Khorakiwala’s bet on antibiotic discovery and development, even as Big Pharma companies in developed economies stopped such research in favour of more lucrative drugs.
The company also secured regulatory approval for Zaynich in India last week and plans to launch domestically in about five months, Khorakiwala said in an interview. It has also filed for regulatory approval in Europe and the UK, and expects approvals this year, and launches a year later.
Fresh off the scientific success, Wockhardt has set its focus on the next big task—selling the drug in the American and global market. Wockhardt expects to launch Zaynich in the US in the next six to eight months.
“We have a distance to cover, where we establish a business organization,” said Khorakiwala. “Communicating and marketing a new molecule is very different from what we used to do in the generic space, where you need more of a commercial organization. For new drugs, you require a scientific and medical-oriented organization.”
A new drug—technically called a new chemical entity or NCE—is one that has never before been approved by medical regulators. The first NCE from India was enmetazobactam—another antibiotic for treatment of UTI—developed by Chennai-based Orchid Pharma and European biopharma Allecra Therapeutics in 2024.
Unlike generics or copycat drugs, which are sold to distributors and don’t require brand marketing or outreach to doctors in the US, selling branded NCEs is a different ballgame, one that requires physician education, direct advertising, and rebate and formulary negotiations. In Wockhardt’s case, since Zaynich is for severe ICU cases, the physician education and direct advertising costs will be significantly lower, as it will focus on hospital outreach.
Khorakiwala expects peak sales of about $1.5 billion globally for Zaynich. “The US price point today for these kinds of new antibiotics is over $10,000 per treatment. And India would be a fraction of that—15-20% of that cost,” he said.
Wockhardt’s stock surged over 16% intraday on Monday before closing up 5.25% at ₹2,138 apiece on the NSE. In the past year, Wockhardt’s share price has increased by 46.86%, significantly outperforming benchmark Nifty Pharma, which has risen 13.18% in the same period.
The road ahead
To commercialize the drug in the US, the company initially evaluated partnerships with big pharma firms earlier.
“We were looking at a certain value for the molecule we have,” said Khorakiwala. “We had simultaneously created an option to do it ourselves. And looking at all the possibilities available to us, we decided to go with ourselves.”
Wockhardt is setting up a leadership team to handle the key profiles in medical, sales and marketing, market access, etc., in the US. Operational tasks like sales force will be outsourced to a third party firm, said Khorakiwala.
This forms the base for its portfolio, as the company expects more of its molecules to hit the market in the next few years. A similar model is being created for Europe as well.
“They will need to make meaningful commercial investments to build this, although this drug will not be salesforce intensive,” said Vishal Manchanda, pharma analyst at Systematix Group, adding that given the drug’s potential, it may not need a massive push and find patients on its own.
In its Phase III trials, the drug demonstrated better efficacy compared to meropenem—another antibiotic used to treat severe bacterial infections—with a response rate of 89% versus 68.4%.
Companies can spend hundreds of millions of dollars on sales and marketing new drugs in the US. Sun Pharma, which launched two new drugs that it licensed in FY26, had outlined a commercialization budget of $100 million for a year. To be sure, Sun Pharma did not develop the drugs in their R&D labs—it acquired the companies that developed them.
Analysts and investors believe that Wockhardt’s marketing costs may be significantly lower, given the nature of its drug, which is a last-line antibiotic used in life-threatening cases, and involves direct outreach to hospitals.
Plus, Zaynich’s superior efficacy may make the process of introducing it to the market and acceptance easier, an investor who wished to remain anonymous explained.
Wockhardt doesn’t see liquidity as an issue, and has no immediate plans to raise funds, said Khorakiwala. Instead, the company’s focus is on advancing its R&D and product pipeline.
The product pipeline
Zaynich (cefepime and zidebactam), is only one of six antibiotics being developed by Wockhardt.
All of these drugs address a growing global health challenge of antimicrobial resistance, where microbes like bacteria develop resistance to existing medications, leading to severe and fatal infections.
All six of Wockhardt’s molecules received the Qualified Infectious Disease Product (QIDP) and fast track designations from the US FDA, which makes them eligible for fast-track development and priority review, speeding up the trial process and reducing cost.
However, Zaynich is the only drug that has full US FDA approval for marketing and sales, while two others—Miqnaf and Emrok—are already approved in India.
Wockhardt has a patent for all the six novel drugs in its pipeline. The patent for Zaynich will continue for 10-11 years, Khorakiwala said.
Big pharma firms exited antibiotic research over 20 years back, chasing more lucrative cancer and non-communicable disease research. Khorakiwala’s bet has been on the increasing need for antibiotics, and the massive gap in research.
