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

Products without listed protection (2)

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