Her2 Negative Breast Cancer Therapeutics
1. Afinitor patent expiration
Treatment: Treatment of patients with tuberous sclerosis complex (tsc) who have subependymal giant cell astrocytoma (sega) that requires therapeutic intervention but cannot be curatively resected.; Treatment of ...
AFINITOR's oppositions filed in EPO
AFINITOR IPR and PTAB Proceedings
Can you believe AFINITOR received compensation for the extended wait time during the regulatory approval process?
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US6004973 | NOVARTIS | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul, 2016
(9 years ago) | |
| US7741338 | NOVARTIS | Macrolides |
Dec, 2019
(6 years ago) | |
| US8778962 | NOVARTIS | Treatment of solid tumors with rapamycin derivatives |
Feb, 2022
(3 years ago) | |
| US8436010 | NOVARTIS | Treatment of solid tumors with rapamycin derivatives |
Feb, 2022
(3 years ago) | |
|
US7297703 (Pediatric) | NOVARTIS | Macrolides |
Jun, 2020
(5 years ago) | |
|
US5665772 (Pediatric) | NOVARTIS | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar, 2020
(5 years ago) | |
| US7297703 | NOVARTIS | Macrolides |
Dec, 2019
(6 years ago) | |
| US5665772 | NOVARTIS | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep, 2019
(6 years ago) | |
|
US6004973 (Pediatric) | NOVARTIS | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan, 2017
(8 years ago) | |
| US9006224 | NOVARTIS | Neuroendocrine tumor treatment |
Jul, 2028
(2 years from now) | |
|
US8436010 (Pediatric) | NOVARTIS | Treatment of solid tumors with rapamycin derivatives |
Aug, 2022
(3 years ago) | |
|
US8778962 (Pediatric) | NOVARTIS | Treatment of solid tumors with rapamycin derivatives |
Aug, 2022
(3 years ago) | |
| US8410131 | NOVARTIS | Cancer treatment |
Nov, 2025
(2 months ago) | |
|
US8410131 (Pediatric) | NOVARTIS | Cancer treatment |
May, 2026
(3 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-630) | Oct 29, 2013 |
| New Chemical Entity Exclusivity(NCE) | Mar 30, 2014 |
| New Indication(I-638) | May 05, 2014 |
| New Indication(I-650) | Apr 26, 2015 |
| New Indication(I-655) | Jul 20, 2015 |
| Pediatric Exclusivity(PED) | Apr 29, 2018 |
| Orphan Drug Exclusivity(ODE) | Apr 26, 2019 |
| Orphan Drug Exclusivity(ODE-11) | May 05, 2018 |
| New Indication(I-724) | Feb 26, 2019 |
| Orphan Drug Exclusivity(ODE-24) | Apr 26, 2019 |
| Orphan Drug Exclusivity(ODE-108) | Feb 26, 2023 |
Drugs and Companies using EVEROLIMUS ingredient
NCE-1 date: 26 October, 2014
Market Authorisation Date: 09 July, 2010
Dosage: TABLET
How can I launch a generic of AFINITOR before it's drug patent expiration?
More Information on Dosage
AFINITOR family patents
2. Ibrance patent expiration
Treatment: Palbociclib for hr-pos. her2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after...
IBRANCE'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. | ||||
| US7208489 | PFIZER | 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones |
Jan, 2023
(2 years ago) | |
| US6936612 | PFIZER | 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones |
Jan, 2023
(2 years ago) | |
| US10723730 | PFIZER | Solid forms of a selective CDK4/6 inhibitor |
Feb, 2034
(8 years from now) | |
| USRE47739 | PFIZER | 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones |
Mar, 2027
(1 year, 1 month from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US7456168 | PFIZER | 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones |
Jan, 2023
(2 years ago) | |
|
USRE47739 (Pediatric) | PFIZER | NA |
Sep, 2027
(1 year, 7 months from now) | |
|
US10723730 (Pediatric) | PFIZER | NA |
Aug, 2034
(8 years from now) | |
|
US11065250 (Pediatric) | PFIZER | NA |
Feb, 2037
(11 years from now) | |
| US11065250 | PFIZER | Solid dosage forms of palbociclib |
Aug, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-725) | Feb 19, 2019 |
| New Chemical Entity Exclusivity(NCE) | Feb 03, 2020 |
| M(M-14) | Sep 16, 2028 |
| Pediatric Exclusivity(PED) | Mar 16, 2029 |
Drugs and Companies using PALBOCICLIB ingredient
NCE-1 date: 16 March, 2028
Market Authorisation Date: 03 February, 2015
Dosage: CAPSULE
How can I launch a generic of IBRANCE before it's drug patent expiration?
More Information on Dosage
IBRANCE family patents
3. Itovebi patent
expiration
Treatment: Combination with palbociclib and fulvestrant for treatment of adults with endocrine-resistant pik3ca-mutated hr-positive her2-negative locally advanced or metastatic breast cancer following recurrence...
| 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. | ||||
| US9650393 | GENENTECH INC | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(10 years from now) | |
| US8242104 | GENENTECH INC | Benzoxazepin P13K inhibitor compounds and methods of use |
Sep, 2030
(4 years from now) | |
| US10851091 | GENENTECH INC | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(10 years from now) | |
| US11028100 | GENENTECH INC | Polymorphs and solid forms of (s)-2-((2-((s)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)amino)propanamide, and methods of production |
Apr, 2038
(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). | ||||
| US12410189 | GENENTECH INC | NA |
Jun, 2038
(12 years from now) | |
| US11760753 | GENENTECH INC | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(10 years from now) | |
| US8343955 | GENENTECH INC | Benzoxazepin PI3K inhibitor compounds and methods of use |
Sep, 2030
(4 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 10, 2029 |
Drugs and Companies using INAVOLISIB ingredient
NCE-1 date: 10 October, 2028
Market Authorisation Date: 10 October, 2024
Dosage: TABLET
More Information on Dosage
ITOVEBI family patents
4. Kisqali patent expiration
Treatment: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negat...
| 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. | ||||
| US9193732 | NOVARTIS | Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof |
Nov, 2031
(5 years from now) | |
| US8415355 | NOVARTIS | Pyrrolopyrimidine compounds and their uses |
Mar, 2031
(5 years from now) | |
| US8685980 | NOVARTIS | Pyrrolopyrimidine compounds and their uses |
May, 2030
(4 years from now) | |
| US8324225 | NOVARTIS | Pyrrolopyrimidine compounds and their uses |
Jun, 2028
(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). | ||||
| US9868739 | NOVARTIS | Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof |
Nov, 2031
(5 years from now) | |
| US9416136 | NOVARTIS | Pyrrolopyrimidine compounds and their uses |
Aug, 2029
(3 years from now) | |
| US8962630 | NOVARTIS | Pyrrolopyrimidine compounds and their uses |
Dec, 2029
(3 years from now) | |
| US12064434 | NOVARTIS | Ribociclib tablet |
Apr, 2036
(10 years from now) | |
| US12419894 | NOVARTIS | NA |
Apr, 2036
(10 years from now) | |
| US10799506 | NOVARTIS | Ribociclib tablet |
Apr, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-783) | Jul 18, 2021 |
| New Indication(I-784) | Jul 18, 2021 |
| New Chemical Entity Exclusivity(NCE) | Mar 13, 2022 |
| New Patient Population(NPP) | Dec 10, 2024 |
| New Indication(I-950) | Sep 17, 2027 |
Drugs and Companies using RIBOCICLIB SUCCINATE ingredient
NCE-1 date: 13 March, 2021
Market Authorisation Date: 13 March, 2017
Dosage: TABLET
How can I launch a generic of KISQALI before it's drug patent expiration?
More Information on Dosage
KISQALI family patents
5. Lynparza patent expiration
Treatment: Adjuvant treatment of patients with gbrca-mutated human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy...
LYNPARZA's oppositions filed in EPO
LYNPARZA 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. | ||||
| US7151102 | ASTRAZENECA | Phthalazinone derivatives |
Apr, 2022
(3 years ago) | |
| US7981889 | ASTRAZENECA | Phthalazinone derivatives |
Oct, 2024
(1 year, 2 months ago) | |
| US7449464 | ASTRAZENECA | Phthalazinone derivatives |
Sep, 2027
(1 year, 7 months from now) | |
| US8247416 | ASTRAZENECA | Phthalazinone derivative |
Sep, 2028
(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). | ||||
| US8143241 | ASTRAZENECA | DNA damage repair inhibitors for treatment of cancer |
Aug, 2027
(1 year, 7 months from now) | |
| US8912187 | ASTRAZENECA | Phthalazinone derivatives |
Mar, 2024
(1 year, 9 months ago) | |
| US11970530 | ASTRAZENECA | Methods of treating homologous recombination deficient cancer |
Oct, 2041
(15 years from now) | |
| US9566276 | ASTRAZENECA | Phthalazinone derivatives |
Mar, 2024
(1 year, 9 months ago) | |
| US8859562 | ASTRAZENECA | Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer |
Aug, 2031
(5 years from now) | |
| US8071579 | ASTRAZENECA | DNA damage repair inhibitors for the treatment of cancer |
Aug, 2027
(1 year, 7 months from now) | |
| US9169235 | ASTRAZENECA | Phthalazinone derivatives |
Mar, 2024
(1 year, 9 months ago) | |
| US11975001 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(3 years from now) | |
| US11633396 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one |
Oct, 2029
(3 years from now) | |
| US8475842 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Dec, 2029
(3 years from now) | |
| US12048695 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(3 years from now) | |
| US12178816 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(3 years from now) | |
| US12144810 | ASTRAZENECA | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2019 |
| New Product(NP) | Aug 17, 2020 |
| New Indication(I-762) | Jan 12, 2021 |
| New Indication(I-776) | Dec 19, 2021 |
| Orphan Drug Exclusivity(ODE) | Dec 19, 2021 |
| Orphan Drug Exclusivity(ODE-83) | Dec 19, 2021 |
| New Indication(I-818) | Dec 27, 2022 |
| New Indication(I-831) | May 08, 2023 |
| New Indication(I-832) | May 19, 2023 |
| Orphan Drug Exclusivity(ODE-180) | Aug 17, 2024 |
| Orphan Drug Exclusivity(ODE-181) | Aug 17, 2024 |
| New Indication(I-885) | Mar 11, 2025 |
| Orphan Drug Exclusivity(ODE-226) | Dec 19, 2025 |
| New Indication(I-914) | May 31, 2026 |
| Orphan Drug Exclusivity(ODE-283) | Dec 27, 2026 |
| Orphan Drug Exclusivity(ODE-306) | May 08, 2027 |
Drugs and Companies using OLAPARIB ingredient
NCE-1 date: 19 December, 2018
Market Authorisation Date: 17 August, 2017
Dosage: TABLET; CAPSULE
How can I launch a generic of LYNPARZA before it's drug patent expiration?
More Information on Dosage
LYNPARZA family patents
6. Orserdu patent expiration
Treatment: Treatment of an er-positive breast cancer; Treatment of an er-positive breast cancer following at least one line of endocrine therapy
| 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. | ||||
| US7612114 | STEMLINE THERAP | Selective estrogen receptor modulator |
Aug, 2026
(7 months from now) | |
| US8399520 | STEMLINE THERAP | Selective estrogen receptor modulator |
Dec, 2025
(14 days ago) | |
| US10385008 | STEMLINE THERAP | Polymorphic forms of RAD1901-2HCL |
Jan, 2038
(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). | ||||
| US11819480 | STEMLINE THERAP | Methods for treating cancer |
Feb, 2037
(11 years from now) | |
| US10420734 | STEMLINE THERAP | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2036
(10 years from now) | |
| US10745343 | STEMLINE THERAP | Polymorphic forms of RAD1901-2HCl |
Jan, 2038
(11 years from now) | |
| US10071066 | STEMLINE THERAP | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2034
(8 years from now) | |
| US11779552 | STEMLINE THERAP | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2034
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 27, 2028 |
Drugs and Companies using ELACESTRANT HYDROCHLORIDE ingredient
NCE-1 date: 27 January, 2027
Market Authorisation Date: 27 January, 2023
Dosage: TABLET
More Information on Dosage
ORSERDU family patents
7. Piqray patent expiration
Treatment: In combination with fulvestrant for treatment of adults with hr-positive, her-2-negative, pik3ca-mutated, advanced or metastatic breast cancer
| 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. | ||||
| US8227462 | NOVARTIS | Pyrrolidine-1,2-dicarboxamide derivatives |
Apr, 2033
(7 years from now) | |
| US8476268 | NOVARTIS | Pyrrolidine-1,2-dicarboxamide derivatives |
Sep, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 24, 2024 |
| New Indication(I-937) | Jan 18, 2027 |
Drugs and Companies using ALPELISIB ingredient
NCE-1 date: 25 May, 2023
Market Authorisation Date: 24 May, 2019
Dosage: TABLET
More Information on Dosage
PIQRAY family patents
8. Talzenna patent expiration
Treatment: Treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca)-mutated (gbrcam) human epidermal growth factor receptor 2 (her2)-negative locall...
| 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. | ||||
| US10189837 | PFIZER | Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt |
Oct, 2031
(5 years from now) | |
| US8420650 | PFIZER | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) |
Jul, 2029
(3 years from now) | |
| US8735392 | PFIZER | Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt |
Oct, 2031
(5 years from now) | |
| US8012976 | PFIZER | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) |
Oct, 2029
(3 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). | ||||
| US9820985 | PFIZER | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) |
Jul, 2029
(3 years from now) | |
| US10780088 | PFIZER | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) |
Jul, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 16, 2023 |
| New Indication(I-920) | Jun 20, 2026 |
Drugs and Companies using TALAZOPARIB TOSYLATE ingredient
NCE-1 date: 16 October, 2022
Market Authorisation Date: 20 June, 2023
Dosage: CAPSULE
More Information on Dosage
TALZENNA family patents
9. Verzenio patent expiration
Treatment: In combination with fulvestrant for the treatment of adult patients with hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progres...
| 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. | ||||
| US7855211 | ELI LILLY AND CO | Protein kinase inhibitors |
Sep, 2031
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-768) | Feb 26, 2021 |
| New Chemical Entity Exclusivity(NCE) | Sep 28, 2022 |
| New Indication(I-877) | Oct 12, 2024 |
| New Patient Population(NPP) | Oct 12, 2024 |
Drugs and Companies using ABEMACICLIB ingredient
NCE-1 date: 28 September, 2021
Market Authorisation Date: 28 September, 2017
Dosage: TABLET
More Information on Dosage
VERZENIO family patents