Metastatic Breast Cancer Therapeutics

1. Faslodex patent expiration

Treatment: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen ther...

FASLODEX IPR and PTAB Proceedings
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).
US6774122

(Pediatric)

ASTRAZENECA Formulation
Jul, 2021

(4 years ago)

US8466139

(Pediatric)

ASTRAZENECA Formulation
Jul, 2021

(4 years ago)

US8329680

(Pediatric)

ASTRAZENECA Formulation
Jul, 2021

(4 years ago)

US7456160 ASTRAZENECA Formulation
Jan, 2021

(5 years ago)

US8466139 ASTRAZENECA Formulation
Jan, 2021

(5 years ago)

US8329680 ASTRAZENECA Formulation
Jan, 2021

(5 years ago)

US6774122 ASTRAZENECA Formulation
Jan, 2021

(5 years ago)

US7456160

(Pediatric)

ASTRAZENECA Formulation
Jul, 2021

(4 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-126) Sep 09, 2013
Pediatric Exclusivity(PED) Mar 09, 2014
M(M-103) May 17, 2014
M(M-123) Nov 09, 2015
New Indication(I-725) Feb 19, 2019
New Indication(I-749) Aug 25, 2020

Drugs and Companies using FULVESTRANT ingredient

Market Authorisation Date: 25 April, 2002

Dosage: SOLUTION

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

FASLODEX family patents

Family Patents

2. Halaven patent expiration

Treatment: Treatment of patients with metastatic breast cancer

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).
US8097648 EISAI INC Methods and compositions for use in treating cancer
Jan, 2021

(4 years ago)

US6469182 EISAI INC Intermediates in the preparation of macrocyclic analogs
Jun, 2019

(6 years ago)

US7470720 EISAI INC Methods and compositions for use in treating cancer
Jun, 2019

(6 years ago)

US6214865 EISAI INC Macrocyclic analogs and methods of their use and preparation
Jun, 2019

(6 years ago)

US6214865

(Pediatric)

EISAI INC Macrocyclic analogs and methods of their use and preparation
Jan, 2024

(1 year, 11 months ago)

USRE46965 EISAI INC Intermediates for the preparation of analogs of Halichondrin B
Jan, 2027

(11 months from now)

USRE46965

(Pediatric)

EISAI INC Intermediates for the preparation of analogs of Halichondrin B
Jul, 2027

(1 year, 5 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 15, 2015
New Indication(I-721) Jan 28, 2019
Orphan Drug Exclusivity(ODE) Jan 28, 2023
Orphan Drug Exclusivity(ODE-107) Jan 28, 2023
M(M-280) Sep 13, 2025
Pediatric Exclusivity(PED) Mar 13, 2026

Drugs and Companies using ERIBULIN MESYLATE ingredient

NCE-1 date: 13 March, 2025

Market Authorisation Date: 15 November, 2010

Dosage: SOLUTION

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

HALAVEN family patents

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. 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-base...

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

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

Family Patents

5. 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

Family Patents

6. Tryptyr patent expiration

Treatment: Treatment of the signs and symptoms of dry eye disease (ded)

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).
US11850221 ALCON LABS INC Ophthalmic pharmaceutical compositions and uses thereof
Dec, 2042

(16 years from now)

US10028920 ALCON LABS INC Methods for treating occular irritation involving tearing by administering modulators of TRPM8
Sep, 2031

(5 years from now)

US9433679 ALCON LABS INC Use of TRMP8 for treating opthalmic diseases or conditions involving tearing
Sep, 2031

(5 years from now)

US9095609 ALCON LABS INC Ophthalmic composition comprising ws-12 and methods to treat xerophthalmia
Sep, 2031

(5 years from now)

US12336971 ALCON LABS INC NA
Dec, 2042

(16 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 28, 2030

Drugs and Companies using ACOLTREMON ingredient

NCE-1 date: 28 May, 2029

Market Authorisation Date: 28 May, 2025

Dosage: SOLUTION/DROPS

More Information on Dosage

TRYPTYR family patents

Family Patents

7. Tukysa patent expiration

Treatment: Combination treatment with tucatinib and trastuzumab of adults with ras wild-type her2-positive unresectable or metastatic colorectal cancer that has progressed following previous treatment as claimed...

TUKYSA'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.
US7452895 SEAGEN Quinazoline analogs as receptor tyrosine kinase inhibitors
Nov, 2025

(a month ago)

US8648087 SEAGEN N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Apr, 2031

(5 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).
US11666572 SEAGEN Treatment of HER2 positive cancers
Apr, 2038

(12 years from now)

US11504370 SEAGEN Treatment of brain cancer
Mar, 2033

(7 years from now)

US12048698 SEAGEN Treatment of HER2 positive cancers
Apr, 2038

(12 years from now)

US9457093 SEAGEN Solid dispersions of a ERB2 (HER2) inhibitor
Oct, 2032

(6 years from now)

US9693989 SEAGEN N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
May, 2027

(1 year, 3 months from now)

US11207324 SEAGEN Treatment of HER2 positive cancers
Apr, 2038

(12 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 17, 2025
New Indication(I-906) Jan 19, 2026
Orphan Drug Exclusivity(ODE-309) Apr 17, 2027
Orphan Drug Exclusivity(ODE-422) Jan 19, 2030

Drugs and Companies using TUCATINIB ingredient

NCE-1 date: 17 April, 2024

Market Authorisation Date: 17 April, 2020

Dosage: TABLET

More Information on Dosage

TUKYSA family patents

Family Patents

8. Tykerb patent expiration

Treatment: Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress her2 and who have received prior therapy including ...

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.
US8513262 NOVARTIS Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
Jan, 2019

(7 years ago)

US8821927 NOVARTIS Pharmaceutical composition
Sep, 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).
US6727256 NOVARTIS Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
Jan, 2019

(7 years ago)

US6713485 NOVARTIS Heterocyclic compounds
Sep, 2020

(5 years ago)

US6391874 NOVARTIS Fused heterocyclic compounds as protein tyrosine kinase inhibitors
Jul, 2017

(8 years ago)

US7157466 NOVARTIS Quinazoline ditosylate salt compounds
Nov, 2021

(4 years ago)

US6828320 NOVARTIS Heterocyclic compounds
Jul, 2017

(8 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 13, 2012
New Indication(I-620) Jan 29, 2013
M(M-235) Dec 06, 2021

Drugs and Companies using LAPATINIB DITOSYLATE ingredient

NCE-1 date: 14 March, 2011

Market Authorisation Date: 13 March, 2007

Dosage: TABLET

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

TYKERB family patents

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 Read More

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

Family Patents