Philadelphia Chromosome Positive Cml Therapeutics

1. Gleevec patent expiration

Treatment: A method for treating a tumor disease; Gleevec is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (gist)

GLEEVEC IPR and PTAB Proceedings
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.
USRE43932 NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Jul, 2018

(7 years ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5521184

(Pediatric)

NOVARTIS Pyrimidine derivatives and processes for the preparation thereof
Jul, 2015

(10 years ago)

US6894051 NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
May, 2019

(6 years ago)

US5521184 NOVARTIS Pyrimidine derivatives and processes for the preparation thereof
Jan, 2015

(11 years ago)

USRE43932 NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Jan, 2019

(6 years ago)

US6958335 NOVARTIS Treatment of gastrointestinal stromal tumors
Dec, 2021

(4 years ago)

US7544799 NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Jan, 2019

(6 years ago)

US7544799

(Pediatric)

NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Jul, 2019

(6 years ago)

USRE43932

(Pediatric)

NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Jul, 2019

(6 years ago)

US6894051

(Pediatric)

NOVARTIS Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Nov, 2019

(6 years ago)

US6958335

(Pediatric)

NOVARTIS Treatment of gastrointestinal stromal tumors
Jun, 2022

(3 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-583) Dec 19, 2011
Orphan Drug Exclusivity(ODE) Jan 25, 2020
New Indication(I-666) Jan 25, 2016
Orphan Drug Exclusivity(ODE-40) Jan 25, 2020

Drugs and Companies using IMATINIB MESYLATE ingredient

Market Authorisation Date: 10 May, 2001

Dosage: CAPSULE; TABLET

How can I launch a generic of GLEEVEC before it's drug patent expiration?
More Information on Dosage

GLEEVEC family patents

Family Patents

2. Scemblix patent expiration

Treatment: Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml)

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.
US8829195 NOVARTIS Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Oct, 2035

(9 years from now)

US11407735 NOVARTIS Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
May, 2040

(14 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).
US12252479 NOVARTIS Crystalline forms OF N-[4-(chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
May, 2040

(14 years from now)

US12252478 NOVARTIS Crystalline forms of N-[4-(chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
May, 2040

(14 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 29, 2026
New Indication(I-953) Oct 29, 2027
New Indication(I-954) Oct 29, 2027
ODE*(ODE*) Oct 29, 2028
Orphan Drug Exclusivity(ODE-381) Oct 29, 2028
Orphan Drug Exclusivity(ODE-382) Oct 29, 2028
Orphan Drug Exclusivity(ODE-499) Oct 29, 2031
Orphan Drug Exclusivity(ODE-500) Oct 29, 2031

Drugs and Companies using ASCIMINIB HYDROCHLORIDE ingredient

NCE-1 date: 29 October, 2025

Market Authorisation Date: 29 October, 2021

Dosage: TABLET

More Information on Dosage

SCEMBLIX family patents

Family Patents