Pharsight

1. Fetroja patents expiration

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.
US9238657	SHIONOGI INC	Cephalosporin having catechol group	Nov, 2033 (9 years from now)
US10004750	SHIONOGI INC	Salt of cephalosporin derivative, its crystalline solid and a method of manufacturing thereof	Sep, 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).
US9949982	SHIONOGI INC	Preparation containing cephalosporin having a catechol moiety	Sep, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 14, 2024
New Indication(I-844)	Sep 25, 2023
Generating Antibiotic Incentives Now(GAIN)	Nov 14, 2029

Drugs and Companies using CEFIDEROCOL SULFATE TOSYLATE ingredient

NCE-1 date: 14 November, 2028

Market Authorisation Date: 14 November, 2019

Treatment: Method of treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp/vabp) comprising administering cefiderocol sulfate tosylate

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription

FETROJA family patents

2. Jakafi patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP16152794A	2019-09-06	Generics (UK) Ltd	Revoked
EP16197502A	2019-06-28	Concert Pharmaceuticals, Inc.	Granted and Under Opposition
EP08770794A	2014-12-19	Actavis Group PTC ehf	Patent maintained as amended
EP08770794A	2014-12-19	Generics [UK] Ltd (trading as Mylan)	Patent maintained as amended
EP06839328A	2012-06-21	Fresenius Kabi Deutschland GmbH	Opposition procedure closed

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.
US9662335	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors	Dec, 2026 (2 years from now)
US7598257	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors	Dec, 2027 (3 years from now)
US8415362	INCYTE CORP	Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors	Dec, 2027 (3 years from now)
US8722693	INCYTE CORP	Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Jun, 2028 (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).
US9814722	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors	Dec, 2026 (2 years from now)
US9079912	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors	Dec, 2026 (2 years from now)
US9079912 (Pediatric)	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors	Jun, 2027 (3 years from now)
US9814722 (Pediatric)	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors	Jun, 2027 (3 years from now)
US8829013	INCYTE CORP	Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Jun, 2028 (4 years from now)
US8822481	INCYTE CORP	Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Jun, 2028 (4 years from now)
US10016429	INCYTE CORP	Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Jun, 2028 (4 years from now)
US8415362 (Pediatric)	INCYTE CORP	Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors	Jun, 2028 (4 years from now)
US7598257 (Pediatric)	INCYTE CORP	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors	Jun, 2028 (4 years from now)
US8822481 (Pediatric)	INCYTE CORP	Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Dec, 2028 (4 years from now)
US8722693 (Pediatric)	INCYTE CORP	Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Dec, 2028 (4 years from now)
US8829013 (Pediatric)	INCYTE CORP	Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Dec, 2028 (4 years from now)
US10016429 (Pediatric)	INCYTE CORP	Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile	Dec, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-373)	Sep 22, 2028
New Chemical Entity Exclusivity(NCE)	Nov 16, 2016
Orphan Drug Exclusivity(ODE)	Dec 04, 2021
New Indication(I-872)	Sep 22, 2024
New Indication(I-799)	May 24, 2022
Orphan Drug Exclusivity(ODE-238)	May 24, 2026
New Indication(I-699)	Dec 04, 2017
M(M-285)	Dec 19, 2025
Pediatric Exclusivity(PED)	Mar 22, 2029
Orphan Drug Exclusivity(ODE-19)	Nov 16, 2018
Orphan Drug Exclusivity(ODE-79)	Dec 04, 2021

Drugs and Companies using RUXOLITINIB PHOSPHATE ingredient

NCE-1 date: 22 March, 2028

Market Authorisation Date: 16 November, 2011

Treatment: For treatment of steroid-refractory acute graft-versus-host disease (agvhd); For treatment of polycythemia vera (pv) in patients who have had an inadequate response to or are intolerant of hydroxyurea...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg, 10 mg, 15 mg, 20 mg, and 25 mg	17 Dec, 2015	1		12 Jun, 2028

Strength	Dosage	Availability
EQ 25MG BASE	TABLET;ORAL	Prescription
EQ 20MG BASE	TABLET;ORAL	Prescription
EQ 5MG BASE	TABLET;ORAL	Prescription
EQ 10MG BASE	TABLET;ORAL	Prescription
EQ 15MG BASE	TABLET;ORAL	Prescription

JAKAFI family patents

3. Recarbrio patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8487093	MSD MERCK CO	β-lactamase inhibitors	Nov, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 16, 2024
Generating Antibiotic Incentives Now(GAIN)	Jul 16, 2029

Drugs and Companies using CILASTATIN SODIUM; IMIPENEM; RELEBACTAM ingredient

NCE-1 date: 16 July, 2028

Market Authorisation Date: 16 July, 2019

Treatment: Treatment of complicated urinary tract infections, including pyelonephritis (cuti)

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	POWDER;INTRAVENOUS	Prescription

RECARBRIO family patents

4. Tasigna patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10173956A	2017-11-01	D Young & Co LLP	Patent maintained as amended
EP10781781A	2016-11-17	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition
EP10781781A	2016-11-17	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10781781A	2016-11-17	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP10781781A	2016-11-17	Generics (U.K.) Limited	Granted and Under Opposition
EP10781781A	2016-11-14	Fresenius Kabi Deutschland GmbH	Granted and Under Opposition
EP07820560A	2016-06-23	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP07820560A	2016-06-23	medac Gesellschaft für klinische Spezialpräparate mbH	Patent maintained as amended
EP07820560A	2016-06-22	Generics [UK] Limited	Patent maintained as amended
EP07820560A	2016-06-22	Strawman Limited	Patent maintained as amended
EP06800109A	2013-03-13	Actavis Group Ptc Ehf	Revoked
EP06800109A	2013-03-08	D YOUNG & CO	Revoked

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.
US7169791	NOVARTIS	Inhibitors of tyrosine kinases	Jul, 2023 (9 months ago)
US8415363	NOVARTIS	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jul, 2026 (2 years from now)
US8163904	NOVARTIS	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide	Aug, 2028 (4 years from now)
US9061029	NOVARTIS	Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity	Apr, 2032 (7 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).
US7169791 (Pediatric)	NOVARTIS	Inhibitors of tyrosine kinases	Jan, 2024 (3 months ago)
US8389537	NOVARTIS	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jul, 2026 (2 years from now)
US8501760	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jul, 2026 (2 years from now)
US8389537 (Pediatric)	NOVARTIS	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jan, 2027 (2 years from now)
US8501760 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jan, 2027 (2 years from now)
US8415363 (Pediatric)	NOVARTIS	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jan, 2027 (2 years from now)
US8293756	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Sep, 2027 (3 years from now)
US8293756 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Mar, 2028 (3 years from now)
US8163904 (Pediatric)	NOVARTIS	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide	Feb, 2029 (4 years from now)
US9061029 (Pediatric)	NOVARTIS	Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity	Oct, 2032 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-380)	Sep 23, 2028
New Indication(I-627)	Jun 17, 2013
New Chemical Entity Exclusivity(NCE)	Oct 29, 2012
Orphan Drug Exclusivity(ODE)	Oct 29, 2014
New Dosing Schedule(D-170)	Dec 22, 2020
Pediatric Exclusivity(PED)	Mar 23, 2029
New Patient Population(NPP)	Mar 22, 2021
Orphan Drug Exclusivity(ODE-171)	Mar 22, 2025
Orphan Drug Exclusivity(ODE-172)	Mar 22, 2025

Drugs and Companies using NILOTINIB HYDROCHLORIDE ingredient

NCE-1 date: 23 March, 2028

Market Authorisation Date: 22 March, 2018

Treatment: Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); A method for the treatment of leukemias; Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml...

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg	17 Oct, 2019	1		07 Apr, 2032
150 mg and 200 mg	08 Nov, 2013	1		18 Jul, 2026

Strength	Dosage	Availability
EQ 150MG BASE	CAPSULE;ORAL	Prescription
EQ 50MG BASE	CAPSULE;ORAL	Prescription
EQ 200MG BASE	CAPSULE;ORAL	Prescription

TASIGNA family patents

5. Xenleta patents expiration

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.
US6753445	NABRIVA	Pleuromutilin derivatives having antibacterial activity	Jul, 2021 (2 years ago)
US8153689	NABRIVA	Pleuromutilin derivatives for the treatment of diseases mediated by microbes	Mar, 2028 (3 years from now)
US8071643	NABRIVA	Pleuromutilin derivatives for the treatment of diseases mediated by microbes	Jan, 2029 (4 years from now)
US9120727	NABRIVA	Process for the preparation of pleuromutilins	May, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Generating Antibiotic Incentives Now(GAIN)	Aug 19, 2029
New Chemical Entity Exclusivity(NCE)	Aug 19, 2024

Drugs and Companies using LEFAMULIN ACETATE ingredient

NCE-1 date: 19 August, 2028

Market Authorisation Date: 19 August, 2019

Treatment: Treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms

Dosage: SOLUTION;INTRAVENOUS; TABLET;ORAL