Pharsight

1. Savaysa patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP08720658A	2018-05-30	Hexal AG	Granted and Under Opposition
EP08720658A	2018-05-30	Generics [UK] Ltd	Granted and Under Opposition
EP02743653A	2013-05-01	Generics [UK] Limited	Opposition rejected

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.
US7365205	DAIICHI SANKYO INC	Diamine derivatives	Apr, 2027 (2 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).
US9149532	DAIICHI SANKYO INC	Pharmaceutical composition	Mar, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-14)	Oct 18, 2026
M(M-243)	Aug 09, 2022
New Chemical Entity Exclusivity(NCE)	Jan 08, 2020

Drugs and Companies using EDOXABAN TOSYLATE ingredient

NCE-1 date: 08 January, 2019

Market Authorisation Date: 08 January, 2015

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
15 mg, 30 mg and 60 mg	28 Jan, 2019	1		28 Mar, 2028

Strength	Dosage	Availability
EQ 15MG BASE	TABLET;ORAL	Prescription
EQ 30MG BASE	TABLET;ORAL	Prescription
EQ 60MG BASE	TABLET;ORAL	Prescription

SAVAYSA family patents

2. Turalio 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.
US8722702	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US9169250	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US8404700	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US7893075	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	May, 2033 (9 years from now)
US10730876	DAIICHI SANKYO INC	Synthesis of a compound that modulates kinases	May, 2036 (12 years from now)
US9802932	DAIICHI SANKYO INC	Solid forms of a compound modulating kinases	May, 2036 (12 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).
US8461169	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity	Apr, 2028 (3 years from now)
US9358235	DAIICHI SANKYO INC	Kinase modulation, and indications therefor	Jun, 2033 (9 years from now)
US10189833	DAIICHI SANKYO INC	Solid forms of a compound modulating kinases	May, 2036 (12 years from now)
US10435404	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)
US10941142	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)
US10961240	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-250)	Aug 02, 2026
New Chemical Entity Exclusivity(NCE)	Aug 02, 2024
ODE(ODE)	Aug 02, 2026

Drugs and Companies using PEXIDARTINIB HYDROCHLORIDE ingredient

NCE-1 date: 03 August, 2023

Market Authorisation Date: 14 October, 2022

Treatment: Treatment of adult patients with symptomatic tenosynovial giant cell tumor (tgct) associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 125MG BASE	CAPSULE;ORAL	Prescription
EQ 200MG BASE	CAPSULE;ORAL	Discontinued

TURALIO family patents

3. Vanflyta 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.
US8883783	DAIICHI SANKYO INC	Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions thereof, and uses therewith	Mar, 2027 (2 years from now)
US7820657	DAIICHI SANKYO INC	Imidazolothiazole compounds for the treatment of disease	Sep, 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).
US8129374	DAIICHI SANKYO INC	Method of using imidazolothiazole compounds for the treatment of disease	Mar, 2027 (2 years from now)
US8557810	DAIICHI SANKYO INC	Imidazolothiazole compounds for the treatment of disease	Mar, 2027 (2 years from now)
US9585892	DAIICHI SANKYO INC	Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions thereof, and uses therewith	Mar, 2027 (2 years from now)
US8865710	DAIICHI SANKYO INC	Methods of treating proliferative diseases	Aug, 2029 (5 years from now)
US7968543	DAIICHI SANKYO INC	Methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea to treat proliferative disease	Aug, 2029 (5 years from now)
US8836218	DAIICHI SANKYO INC	Methods of treatment using combination therapy	Mar, 2030 (5 years from now)
US9555040	DAIICHI SANKYO INC	Methods of treating proliferative diseases	May, 2030 (6 years from now)
US8357690	DAIICHI SANKYO INC	Methods of treatment using combination therapy	Feb, 2031 (6 years from now)
US9675549	DAIICHI SANKYO INC	Tablet containing composite with cyclodextrin	Sep, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-437)	Jul 20, 2030
New Chemical Entity Exclusivity(NCE)	Jul 20, 2028

Drugs and Companies using QUIZARTINIB DIHYDROCHLORIDE ingredient

NCE-1 date: 21 July, 2027

Market Authorisation Date: 20 July, 2023

Treatment: Combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for adult patients with newly diagno...