Novo Nearly Catches Up to Lilly, Clears Ozempic and Wegovy from FDA Drug Shortage List

Novo Nordisk's corporate headquarters in Denmark

Novo Nordisk’s corporate headquarters in Denmark

A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages.

Only one dose of Novo Nordisk’s blockbuster weight-loss therapy Wegovy (semaglutide) remains in shortage, according to a Tuesday update to the FDA’s database that tracks the availability of drugs.

Currently, just Wegovy’s lowest dose of 0.25 mg is tagged as having “limited availability” by the FDA, which has not indicated an estimated date of resolution. The remaining four strengths of Wegovy and all three doses of its sister brand Ozempic (semaglutide) are available.

With Tuesday’s supply update, Novo appears to be catching up to its main competitor Eli Lilly, which on Monday resolved all shortages of its tirzepatide brands Mounjaro and Zepbound. At the time, three doses of Wegovy still had limited availability.

Novo and Lilly currently dominate the lucrative and rapidly growing weight-loss market. Analysts expect the space to expand even more in the coming years, according to a May 2024 analysis from Reuters. BMO Capital Markets forecasts the obesity space to hit $150 billion by 2033, while Leerink has a more optimistic projection of $158 billion by 2032.

Analytics firm GlobalData is more tempered in its expectations, predicting the market’s value to reach $111 billion by 2033.

One of the main barriers for the obesity market is supply and the recent inability of Lilly and Novo to keep up with the insatiable demand for weight-loss medications.

To address the problem, Lilly and Novo have aggressively increased their respective investments in manufacturing infrastructure to try to beef up supplies. In November 2023, Novo unveiled a $6-billion plan to boost its production capacity in Denmark, which will include the construction of a new, 170,000-square-meter facility.

In February 2024, Novo dropped $16.5 billion to acquire contract manufacturer giant Catalent. As part of the acquisition, Novo’s parent Novo Holdings sold three of Catalent’s fill-finish sites to the pharma business.

Novo also pumped $556 million in its Chinese manufacturing operations in March 2024, followed by a $4.1 billion investment in its Clayton, North Carolina site in June, which is “one of the largest manufacturing investments in Novo Nordisk’s history,” the company said at the time. The historic investment will add 1.4 million square feet of production space to the drugmaker’s U.S. footprint.

Lilly has also been ramping up manufacturing spending, including a $2.5 billion commitment to construct a new facility in Germany and a $5.3 billion investment in Indiana, which is the “largest manufacturing investment in our company’s history,” CEO David Ricks said at the time.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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