bendamustine hydrochloride · Cephalon · NDA 022249

Treanda

Earliest generic entry, as listed · earliest of 2 marketed strengths

26 Apr 2031

Blocked by patent: US 8436190 (pediatric extension).

Listed patents · 6 unexpired

14 Orange Book listing rows for 6 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 8436190	drug product	26 Apr 2031	2 listing rows
US 8436190 listing row	drug product	26 Oct 2030	2 strengths · listed 4 Jun 2013
US 8436190 listing row	pediatric extension · sets the listed date	26 Apr 2031	2 strengths
US 8344006	drug product, use U-1402	23 Mar 2030	2 listing rows
US 8344006 listing row	drug product, use U-1402	23 Sep 2029	2 strengths
US 8344006 listing row	pediatric extension	23 Mar 2030	2 strengths
US 8445524	drug substance, drug product, use U-1402	26 Sep 2029	3 listing rows
US 8445524 listing row	drug substance	26 Mar 2029	2 strengths · listed 17 Sep 2013
US 8445524 listing row	drug substance, drug product, use U-1402	26 Mar 2029	2 strengths · listed 4 Jun 2013
US 8445524 listing row	pediatric extension	26 Sep 2029	4 strengths
US 8669279	drug product, use U-1402	26 Sep 2029	2 listing rows
US 8669279 listing row	drug product, use U-1402	26 Mar 2029	2 strengths · listed 30 Oct 2014
US 8669279 listing row	pediatric extension	26 Sep 2029	2 strengths
US 8883836	drug product, use U-1402	26 Sep 2029	2 listing rows
US 8883836 listing row	drug product, use U-1402	26 Mar 2029	2 strengths · listed 13 Nov 2014
US 8883836 listing row	pediatric extension	26 Sep 2029	2 strengths
US 9533955	drug product, use U-1949, U-1952	26 Sep 2029	3 listing rows
US 9533955 listing row	drug product, use U-1949	26 Mar 2029	2 strengths · listed 13 Jan 2017
US 9533955 listing row	drug product, use U-1952	26 Mar 2029	2 strengths · listed 13 Jan 2017
US 9533955 listing row	pediatric extension	26 Sep 2029	2 strengths

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · product	Form	Strength	Approved	Listed expiry
022249 · 001 · RLD	powder, intravenous	100MG/VIAL	20 Mar 2008	26 Apr 2031
022249 · 002 · RLD	powder, intravenous	25MG/VIAL	1 May 2009	26 Apr 2031
022249 · 003 · RLD · discontinued	solution, intravenous	45MG/0.5ML (90MG/ML)	13 Sep 2013	23 Mar 2030
022249 · 004 · RLD · discontinued	solution, intravenous	180MG/2ML (90MG/ML)	13 Sep 2013	23 Mar 2030

Expired or delisted (6)

US 8609863 · — · 12 Jul 2026
US 8791270 · — · 12 Jul 2026
US 8895756 · — · 12 Jul 2026
US 8609863 · product · 12 Jan 2026
US 8791270 · product, use U-1542 · 12 Jan 2026
US 8895756 · product · 12 Jan 2026