Applicant, as named in the Orange Book

Bayer Healthcare Llc

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis

None.

Recent events

25 Oct 2026Miralax · Generic approved 29 Jul 2026
25 Oct 2026Claritin-D 24 Hour · Generic approved 6 Aug 2026
25 Oct 2026Claritin-D 24 Hour · Generic approved 16 Oct 2026

Products without listed protection (13)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Children's Claritin loratadine	loratadine	021891	open now	no listed protection
Claritin loratadine	loratadine	019658	open now	no listed protection
Claritin loratadine	loratadine	020641	open now	no listed protection
Claritin loratadine	loratadine	021891	open now	no listed protection
Claritin loratadine	loratadine	021952	open now	no listed protection
Claritin Hives Relief loratadine	loratadine	019658	open now	no listed protection
Claritin Hives Relief Reditab loratadine	loratadine	020704	open now	no listed protection
Claritin Reditabs loratadine	loratadine	020704	open now	no listed protection
Claritin Reditabs loratadine	loratadine	021993	open now	no listed protection
Claritin-D loratadine; pseudoephedrine sulfate	loratadine; pseudoephedrine sulfate	019670	open now	no listed protection
Claritin-D 24 Hour loratadine; pseudoephedrine sulfate	loratadine; pseudoephedrine sulfate	020470	open now	no listed protection
Lotrimin Ultra butenafine hydrochloride	butenafine hydrochloride	021307	open now	no listed protection
Miralax · 2 strengths polyethylene glycol 3350	polyethylene glycol 3350	022015	open now	no listed protection