Applicant, as named in the Orange Book

Provepharm Sas

Next listed expiry: Provayblue on 8 Jan 2027. 2 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Provayblue NDA 204630 · 2 strengths methylene blue	methylene blue	8 Jan 2027 exclusivity	exclusivity
Bludigo NDA 216264 indigotindisulfonate sodium	indigotindisulfonate sodium	23 Dec 2037 patent	patent

Provayblue · Generic approved · ANDA 219550, Chengdu ShuodeApproved 23 Dec 2025Detected 25 Oct 2026
Provayblue · Exclusivity expires within 90 days M-303Exclusivity expires 8 Jan 2027Detected 24 Oct 2026
Provayblue · Enters 12-month window basis: exclusivityListed date 8 Jan 2027Detected 24 Oct 2026
Provayblue · Exclusivity expires within 90 days M-303Exclusivity expires 8 Jan 2027Detected 24 Oct 2026
Provayblue · Enters 12-month window basis: exclusivityListed date 8 Jan 2027Detected 24 Oct 2026

Products without listed protection (2)

Drug	Ingredient	Earliest generic entry	Basis
Bal NDA 005939 dimercaprol	dimercaprol	open now no listed protection	no listed protection
Zyogreen NDA 218579 indocyanine green	indocyanine green	open now no listed protection	no listed protection