Applicant, as named in the Orange Book

Mylan Ireland Ltd

Next listed expiry: Pretomanid on 14 Aug 2031. 2 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Pretomanid NDA 212862 pretomanid	pretomanid	14 Aug 2031 exclusivity	exclusivity
Yupelri NDA 210598 revefenacin	revefenacin	23 Oct 2039 patent, carve-out possible	patent, carve-out possible

Recent events

Yupelri · Generic tentatively approved · ANDA 218088, Lupin Inc.Tentative approval 15 May 2026Detected 25 Oct 2026

Products without listed protection (2)

Drug	Ingredient	Earliest generic entry	Basis
Arixtra NDA 021345 · 4 strengths fondaparinux sodium	fondaparinux sodium	open now no listed protection	no listed protection
Miacalcin NDA 017808 calcitonin salmon	calcitonin salmon	open now no listed protection	no listed protection