Pharsight

Tasigna is owned by Novartis.

Tasigna contains Nilotinib Hydrochloride.

Tasigna has a total of 14 drug patents out of which 0 drug patents have expired.

Tasigna was authorised for market use on 29 October, 2007.

Tasigna is available in capsule;oral dosage forms.

Tasigna can be used as treatment of newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph + cml); 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), treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml) by administering nilotinib dispersed in a fruit preparation.

The generics of Tasigna are possible to be released after 07 October, 2032.

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

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.
US7169791	NOVARTIS	Inhibitors of tyrosine kinases	Jul, 2023 (3 months from now)
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 (3 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 (5 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 (9 years from now)
These 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 (9 months from now)
US8501760	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jul, 2026 (3 years from now)
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 (3 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 (3 years from now)
US8501760 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jan, 2027 (3 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 (3 years from now)
US8293756	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Sep, 2027 (4 years from now)
US8293756 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Mar, 2028 (4 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 (5 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 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Sep 23, 2028
Pediatric Exclusivity (PED)	Sep 22, 2025

Drugs and Companies using NILOTINIB HYDROCHLORIDE ingredient

Market Authorisation Date: 29 October, 2007

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

Dosage: CAPSULE;ORAL