Pharsight

1. List of Belrapzo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8791270	EAGLE PHARMS	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US10010533	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US9265831	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US9572796	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US9572797	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US11103483	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US8609707	EAGLE PHARMS	Formulations of bendamustine	Aug, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 7, 2022

Market Authorisation Date: 15 May, 2018

Treatment: For the treatment of patients with chronic lymphocytic leukemia; For the treatment of patients with indolent b-cell non-hodgkin lymphoma

Dosage: SOLUTION;IV (INFUSION)

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg/4 mL (25 mg/mL) multiple-dose vials	17 Jul, 2018	1		28 Jan, 2031

Strength	Dosage	Availability
100MG/4ML (25MG/ML)	SOLUTION;IV (INFUSION)	Prescription

2. List of Bendeka drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8791270	EAGLE PHARMS	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US9265831	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US9572797	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US9572796	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US11103483	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US10010533	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (7 years from now)
US8609707	EAGLE PHARMS	Formulations of bendamustine	Aug, 2031 (8 years from now)
US9579384	EAGLE PHARMS	Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration	Mar, 2033 (10 years from now)
US9000021	EAGLE PHARMS	Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration	Mar, 2033 (10 years from now)
US9597398	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US9144568	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US10052385	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US9034908	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US9597399	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US9597397	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)
US9572887	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 7, 2022

Market Authorisation Date: 07 December, 2015

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

Dosage: SOLUTION;IV (INFUSION)

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg/4 mL (25 mg/mL) multiple-dose vials	04 May, 2017	1		15 Mar, 2033

Strength	Dosage	Availability
100MG/4ML (25MG/ML)	SOLUTION;IV (INFUSION)	Prescription

3. List of Treanda drug patents

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).
US8791270	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8609863	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8895756	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (2 years from now)
US8791270 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8609863 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8895756 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (3 years from now)
US8669279	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (6 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)
US8344006	CEPHALON	Liquid formulations of bendamustine	Sep, 2029 (6 years from now)
US8883836 (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)
US8669279 (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
Orphan Drug Exclusivity (ODE)	Dec 7, 2022

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