Applicant, as named in the Orange Book

Esjay Pharma

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis

None.

Recent events

Rocaltrol · Generic approved · ANDA 219796, Humanwell PuracapApproved 27 Feb 2026Detected 25 Oct 2026

Products without listed protection (5)

Drug	Ingredient	Earliest generic entry	Basis
Drisdol NDA 003444 ergocalciferol	ergocalciferol	open now no listed protection	no listed protection
Hiprex NDA 017681 methenamine hippurate	methenamine hippurate	open now no listed protection	no listed protection
Parlodel NDA 017962 · 2 strengths bromocriptine mesylate	bromocriptine mesylate	open now no listed protection	no listed protection
Rocaltrol NDA 018044 · 2 strengths calcitriol	calcitriol	open now no listed protection	no listed protection
Rocaltrol NDA 021068 calcitriol	calcitriol	open now no listed protection	no listed protection