Story perspectives

Judge Dismisses Antitrust Suit Over Orange Book Listing

By Drooid · Sep 24, 2026, 10:27 PM UTC · How we work

Summary

Story summary

U.S. District Judge Lewis Liman dismissed Iron Workers Local 580 Insurance Fund’s antitrust suit against Novartis.
Liman ruled Patent No. 8,101,659 was correctly listed in the FDA’s Orange Book.
Plaintiffs said the listing delayed generic Entresto entry by at least six months.
They alleged Novartis earned over $2 billion in U.S. Entresto sales during that period.
Entresto accounted for 14% of Novartis’s sales last year and fell 42% to $1.31 billion in Q1 2026.

History

Historical Context

The 1984 Hatch-Waxman Act, passed by the U.S. Congress, instituted the FDA’s Orange Book and reshaped pharmaceutical patent enforcement system. It granted manufacturers a 180-day exclusivity period, a benefit valued at roughly $2 billion in annual U.S. sales for new drugs. Today, U.S. District Judge Lewis Liman ruled Novartis’s Entresto patent No. 8,101,659 was listed, mirroring the Act as Iron Workers Local 580 sued over delayed generic entry. The decision underscores how historic exclusivity rules continue to shape drug pricing battles, prompting lawmakers to consider reforms to the Orange Book process.

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Story summary

U.S. District Judge Lewis Liman dismissed Iron Workers Local 580 Insurance Fund’s antitrust suit against Novartis.
Liman ruled Patent No. 8,101,659 was correctly listed in the FDA’s Orange Book.
Plaintiffs said the listing delayed generic Entresto entry by at least six months.
They alleged Novartis earned over $2 billion in U.S. Entresto sales during that period.
Entresto accounted for 14% of Novartis’s sales last year and fell 42% to $1.31 billion in Q1 2026.

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