Pharsight

Treanda is owned by Cephalon.

Treanda contains Bendamustine Hydrochloride.

Treanda has a total of 18 drug patents out of which 0 drug patents have expired.

Treanda was authorised for market use on 20 March, 2008.

Treanda is available in solution;iv (infusion), powder;iv (infusion) dosage forms.

Treanda can be used as for use in the treatment of patients with chronic lymphocytic leukemia (cll) and/or indolent b-cell non-hodgkin lymphoma (nhl), for use in the treatment of patients with indolent b-cell non-hodgkin lymphoma; for use in the treatment of patients with chronic lymphocytic leukemia (cll), for use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma.

The generics of Treanda are possible to be released after 26 April, 2031.

Application	Filing Date	Opposition Party	Legal Status
EP06718390A	2014-01-03	Accord Healthcare	Revoked
EP06718390A	2014-01-02	Gallafent, Alison	Revoked
EP06718390A	2014-01-02	Taylor Wessing LLP	Revoked
EP06718390A	2014-01-02	Bendalis GmbH	Revoked
EP06718390A	2013-12-31	Actavis Group PTC ehf	Revoked
EP06718390A	2013-12-19	LEK Pharmaceuticals d.d.	Revoked
EP06718390A	2013-12-12	Helm AG	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US8895756	November, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Denied	Cephalon, Inc.	AGILA SPECIALTIES INC.
US8436190	December, 2014	Terminated-Settled	Cephalon, Inc.	AGILA SPECIALTIES INC.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8445524	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (6 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8895756	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8609863	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8791270	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8609863 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8791270 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8895756 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8883836	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (6 years from now)
US9533955	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (6 years from now)
US8669279	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (6 years from now)
US8344006	CEPHALON	Liquid formulations of bendamustine	Sep, 2029 (6 years from now)
US9533955 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (6 years from now)
US8883836 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (6 years from now)
US8669279 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (6 years from now)
US8445524 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (6 years from now)
US8344006 (Pediatric)	CEPHALON	Liquid formulations of bendamustine	Mar, 2030 (7 years from now)
US8436190	CEPHALON	Bendamustine pharmaceutical compositions	Oct, 2030 (7 years from now)
US8436190 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Apr, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
ODE* (ODE*)	Dec 7, 2022

Drugs and Companies using BENDAMUSTINE HYDROCHLORIDE ingredient

Market Authorisation Date: 20 March, 2008

Treatment: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma; For use in the treatment of patients with chronic lymphocytic leukemia (cll) and/or indolent b-cell non-hodgkin lymphoma (nhl); For use in the treatment of patients with indolent b-cell non-hodgkin lymphoma; For use in the treatment of patients with chronic lymphocytic leukemia (cll)

Dosage: POWDER;IV (INFUSION); SOLUTION;IV (INFUSION)

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/vial and 100 mg/vial	04 Jun, 2013	10	07 Dec, 2022	26 Oct, 2030	Eligible
90 mg/mL, 0.5 mL and 2 mL in single- dose vials	19 Jun, 2014	1		23 Sep, 2029

Strength	Dosage	Availability
25MG/VIAL	POWDER;IV (INFUSION)	Prescription
100MG/VIAL	POWDER;IV (INFUSION)	Prescription
45MG/0.5ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued
180MG/2ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued