Pharsight

1. Belrapzo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11737745A	2017-07-05	isarpatent - Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann und Partner mbB	Patent maintained as amended
EP11737745A	2017-07-05	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP11737745A	2017-07-05	Wittkopp, Alexander	Patent maintained as amended
EP11737745A	2017-07-05	FRKelly	Patent maintained as amended
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

US8791270	October, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Denied	Cephalon, Inc.	AGILA SPECIALTIES INC.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug 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 (1 year, 8 months from now)
US9265831	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572796	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US11844783	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US11103483	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US10010533	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572797	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US8609707	EAGLE PHARMS	Formulations of bendamustine	Aug, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
ODE(ODE)	Dec 07, 2022

Market Authorisation Date: 15 May, 2018

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

Dosage: SOLUTION;INTRAVENOUS

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;INTRAVENOUS	Prescription

BELRAPZO family patents

2. Bendeka patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11737745A	2017-07-05	isarpatent - Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann und Partner mbB	Patent maintained as amended
EP11737745A	2017-07-05	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP11737745A	2017-07-05	Wittkopp, Alexander	Patent maintained as amended
EP11737745A	2017-07-05	FRKelly	Patent maintained as amended
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

US8791270	October, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Denied	Cephalon, Inc.	AGILA SPECIALTIES INC.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug 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 (1 year, 8 months from now)
US8791270 (Pediatric)	EAGLE PHARMS	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US9265831	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572796	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572797	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US11844783	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US10010533	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US11103483	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US8609707	EAGLE PHARMS	Formulations of bendamustine	Aug, 2031 (7 years from now)
US9034908	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9144568	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9597399	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9597398	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9579384	EAGLE PHARMS	Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration	Mar, 2033 (8 years from now)
US9597397	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9000021	EAGLE PHARMS	Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration	Mar, 2033 (8 years from now)
US10052385	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9572887	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-179)	Dec 07, 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 w...

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

BENDEKA family patents

3. Treanda patents expiration

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.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8445524	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
These drug 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 (1 year, 8 months from now)
US8791270	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (1 year, 8 months from now)
US8609863	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (1 year, 8 months from now)
US8895756 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8609863 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8791270 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8669279	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US8883836	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US9533955	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US8344006	CEPHALON	Liquid formulations of bendamustine	Sep, 2029 (5 years from now)
US8883836 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8445524 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US9533955 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8669279 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8344006 (Pediatric)	CEPHALON	Liquid formulations of bendamustine	Mar, 2030 (5 years from now)
US8436190	CEPHALON	Bendamustine pharmaceutical compositions	Oct, 2030 (6 years from now)
US8436190 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Apr, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-580)	Oct 31, 2011
Orphan Drug Exclusivity(ODE)	Mar 20, 2015
Pediatric Exclusivity(PED)	Sep 20, 2013
ODE(ODE)	Dec 07, 2022
New Chemical Entity Exclusivity(NCE)	Mar 20, 2013

NCE-1 date: 02 May, 2015

Market Authorisation Date: 01 May, 2009

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...

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

TREANDA family patents

4. Vivimusta patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11844784	SLAYBACK PHARMA LLC	Stable pharmaceutical compositions of bendamustine	Jul, 2042 (18 years from now)

Market Authorisation Date: 07 December, 2022

Treatment: NA