Foreign GLP-1 manufacturers, including Lilly, have been placed on the FDA's watchlist

In a significant development, the pharmaceutical industry is embroiled in a legal battle over the sale of alternate versions of brand-name drugs, particularly GLP-1 drugs like Wegovy and Mounjaro.

The proliferation of these knockoffs occurred during shortages of Wegovy and Mounjaro, creating a legal loophole for compounding. This loophole, however, has been a point of contention between the brand-name companies and the compounders.

Novo Nordisk and Eli Lilly, manufacturers of Wegovy and Mounjaro respectively, have been unsuccessfully trying to block compounders from selling alternate versions of their drugs. Despite their efforts, the medicines continue to be available in the market.

Lilly has stated that more action is needed from the FDA and other regulators to stop unlawful compounding. The FDA's action is a response to the issue of illicit tirzepatide imports, a component of Mounjaro.

The specific names of the thirty or more manufacturers of active pharmaceutical ingredients in GLP-1 drugs listed on the US FDA "Green List" are not publicly available. The FDA redacts these names likely due to confidentiality or regulatory reasons.

The shortages of Wegovy and Mounjaro have since ended, but the brand-name companies contend that the continued compounding of their products is illegal. Eli Lilly, in particular, has emphasised the need for stricter regulations to prevent the production and sale of these illicit drugs.

This ongoing legal battle underscores the importance of regulatory oversight in the pharmaceutical industry. The FDA's action against illicit tirzepatide imports is an important first step in addressing this issue and ensuring the safety and efficacy of the drugs available to consumers.