Applicant, as named in the Orange Book

Rosemount

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis

None.

Qdolo · First generic approved · ANDA 219647, Novitium PharmaApproved 26 Jun 2026Detected 25 Oct 2026
Qdolo · Generic approved · ANDA 219647, Novitium PharmaApproved 26 Jun 2026Detected 25 Oct 2026
Fibricor · Enters 12-month window basis: patent, carve-out possibleListed date 20 Aug 2027Detected 24 Oct 2026
Fibricor · Enters 12-month window basis: patent, carve-out possibleListed date 20 Aug 2027Detected 24 Oct 2026

Products without listed protection (1)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Ozobax Ds baclofen	baclofen	208193	open now	no listed protection