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)
US11844783	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9265831	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)
US9572796	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)

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

Drugs and Companies using BENDAMUSTINE HYDROCHLORIDE ingredient

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)
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)
US9265831	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572797	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US9572796	EAGLE PHARMS	Formulations of bendamustine	Jan, 2031 (6 years from now)
US8609707	EAGLE PHARMS	Formulations of bendamustine	Aug, 2031 (7 years from now)
US9597398	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9572887	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)
US9597399	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9144568	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)
US9034908	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)
US9597397	EAGLE PHARMS	Formulations of bendamustine	Mar, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-179)	Dec 07, 2022

Drugs and Companies using BENDAMUSTINE HYDROCHLORIDE ingredient

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. Pemfexy patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP01948214A	2012-10-30	Actavis Deutschland GmbH & Co. KG	Opposition rejected
EP01948214A	2008-01-17	Teva Pharmaceutical Industries Ltd.	Opposition rejected

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7772209	July, 2016	FWD Entered	Eli Lilly and Company	Apotex Inc.
US7772209	July, 2016	FWD Entered	Eli Lilly and Company	Wockhardt Bio AG
US7772209	July, 2016	FWD Entered	Eli Lilly and Company	Teva Pharmaceuticals USA, Inc.
US7772209	July, 2016	FWD Entered	Eli Lilly and Company	Apotex Inc.
US7772209	June, 2016	FWD Entered	Eli Lilly and Company	Wockhardt Bio AG
US7772209	December, 2015	FWD Entered	Eli Lilly and Company	Sandoz Inc.
US7772209	November, 2015	FWD Entered	Eli Lilly and Company	Neptune Generics, LLC
US7772209	June, 2013	Terminated-Denied	Eli Lilly and Company	Accord Healthcare, Inc., USA

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.
US9604990	EAGLE PHARMS	Crystalline forms of pemetrexed diacid and manufacturing processes therefor	Oct, 2035 (11 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).
US7772209	EAGLE PHARMS	Antifolate combination therapies	May, 2022 (1 year, 11 months ago)
US11793813	EAGLE PHARMS	Pemetrexed formulations	Feb, 2036 (11 years from now)

Drugs and Companies using PEMETREXED ingredient

Market Authorisation Date: 08 February, 2020

Treatment: Use of pemetrexed with prior and/or repeated vitamin b12 and folic acid administration in patients with non-squamous non-small cell lung cancer

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
500MG/20ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription

PEMFEXY family patents

4. Ryanodex patents expiration

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).
US9884044	EAGLE PHARMS	Treatment using dantrolene	Jun, 2022 (1 year, 10 months ago)
US8604072	EAGLE PHARMS	Treatment using dantrolene	Jul, 2022 (1 year, 9 months ago)
US8110225	EAGLE PHARMS	Treatment using dantrolene	Dec, 2022 (1 year, 4 months ago)
US8685460	EAGLE PHARMS	Treatment using dantrolene	Feb, 2023 (1 year, 2 months ago)
US7758890	EAGLE PHARMS	Treatment using dantrolene	Jun, 2025 (1 year, 2 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Jul 22, 2021
Orphan Drug Exclusivity(ODE-69)	Jul 22, 2021

Drugs and Companies using DANTROLENE SODIUM ingredient

Market Authorisation Date: 22 July, 2014

Treatment: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk.

Dosage: FOR SUSPENSION;INTRAVENOUS