Applicant, as named in the Orange Book

Mylan Institutional

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis

None.

Recent events

Rimso-50 · Generic approved · ANDA 220173, PharmobedientApproved 7 Jul 2026Detected 25 Oct 2026

Products without listed protection (4)

Drug	Ingredient	Earliest generic entry	Basis
Duraclon NDA 020615 clonidine hydrochloride	clonidine hydrochloride	open now no listed protection	no listed protection
Methadone Hydrochloride NDA 021624 methadone hydrochloride	methadone hydrochloride	open now no listed protection	no listed protection
Rimso-50 NDA 017788 dimethyl sulfoxide	dimethyl sulfoxide	open now no listed protection	no listed protection
Ultiva NDA 020630 · 3 strengths remifentanil hydrochloride	remifentanil hydrochloride	open now no listed protection	no listed protection