Chronic Myeloid Leukemia (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
2. Iclusig patent expiration
Treatment: A method for treating acute lymphoblastic leukemia; A method for treating chronic myeloid leukemia; A method for treating philadelphia chromosome positive acute lymphoblastic leukemia
| 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. | ||||
| US9493470 | TAKEDA PHARMS USA | Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(7 years from now) | |
| US11384086 | TAKEDA PHARMS USA | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1- yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(7 years from now) | |
| US11192897 | TAKEDA PHARMS USA | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(7 years from now) | |
| US8114874 | TAKEDA PHARMS USA | Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors |
Jan, 2027
(1 year, 15 days from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9029533 | TAKEDA PHARMS USA | Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors |
Dec, 2026
(11 months from now) | |
| US11192895 | TAKEDA PHARMS USA | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2017 |
| Orphan Drug Exclusivity(ODE) | Dec 14, 2019 |
| Orphan Drug Exclusivity(ODE-35) | Dec 14, 2019 |
| New Indication(I-849) | Dec 18, 2023 |
| New Indication(I-934) | Mar 19, 2027 |
| Orphan Drug Exclusivity(ODE-472) | Mar 19, 2031 |
Drugs and Companies using PONATINIB HYDROCHLORIDE ingredient
NCE-1 date: 14 December, 2016
Market Authorisation Date: 18 December, 2020
Dosage: TABLET
How can I launch a generic of ICLUSIG before it's drug patent expiration?
More Information on Dosage
ICLUSIG family patents
3. 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
4. Sprycel patent expiration
Treatment: A method for treatment of a cancer, wherein the cancer is chronic myelogenous leukemia; A method for the treatment of cancer
SPRYCEL's oppositions filed in EPO
| 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. | ||||
| US7491725 | BRISTOL MYERS SQUIBB | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Mar, 2026
(2 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
|
US7125875 (Pediatric) | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(5 years ago) | |
|
US7153856 (Pediatric) | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(5 years ago) | |
|
US6596746 (Pediatric) | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Dec, 2020
(5 years ago) | |
| US7125875 | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(5 years ago) | |
| US6596746 | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Jun, 2020
(5 years ago) | |
| US7153856 | BRISTOL MYERS SQUIBB | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(5 years ago) | |
| US8680103 | BRISTOL MYERS SQUIBB | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Feb, 2025
(11 months ago) | |
|
US7491725 (Pediatric) | BRISTOL MYERS SQUIBB | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Sep, 2026
(8 months from now) | |
|
US8680103 (Pediatric) | BRISTOL MYERS SQUIBB | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Aug, 2025
(5 months ago) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-120) | May 21, 2012 |
| Orphan Drug Exclusivity(ODE) | Jun 28, 2013 |
| M(M-94) | Oct 28, 2013 |
| New Patient Population(NPP) | Nov 09, 2020 |
| New Indication(I-791) | Dec 21, 2021 |
| Orphan Drug Exclusivity(ODE-164) | Nov 09, 2024 |
| Orphan Drug Exclusivity(ODE-225) | Dec 21, 2025 |
| Pediatric Exclusivity(PED) | Jun 21, 2026 |
Drugs and Companies using DASATINIB ingredient
Market Authorisation Date: 28 June, 2006
Dosage: TABLET
How can I launch a generic of SPRYCEL before it's drug patent expiration?
More Information on Dosage
SPRYCEL family patents
5. Synribo patent expiration
Treatment: Treatment of patients with leukemia including chronic myeloid/myelogenous leukemia (cml); Treatment of patients with tyrosine kinase inhibitor (tki) resistant or intolerant chronic myeloid/myelogenous...
| 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. | ||||
| USRE45128 | TEVA PHARMS INTL | Cephalotaxane derivatives and their processes of preparation and purification |
Mar, 2019
(6 years ago) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US7842687 | TEVA PHARMS INTL | Cephalotaxane derivatives and their processes of preparation and purification |
Mar, 2019
(6 years ago) | |
| US6987103 | TEVA PHARMS INTL | Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents |
Oct, 2026
(9 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 26, 2017 |
| Orphan Drug Exclusivity(ODE) | Oct 26, 2019 |
| Orphan Drug Exclusivity(ODE-32) | Oct 26, 2019 |
Drugs and Companies using OMACETAXINE MEPESUCCINATE ingredient
NCE-1 date: 26 October, 2016
Market Authorisation Date: 26 October, 2012
Dosage: POWDER
How can I launch a generic of SYNRIBO before it's drug patent expiration?
More Information on Dosage
SYNRIBO family patents