Her2+ Breast Cancer Therapeutics

1. Nerlynx patent expiration

Treatment: Use in combination with capecitabine, for the treatment of adult patients with advanced or metastatic her2-positive breast cancer who have received two or more prior anti-her2 based regimens in the me...

NERLYNX'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.
US6288082 PUMA BIOTECH Substituted 3-cyanoquinolines
Sep, 2019

(6 years ago)

US7399865 PUMA BIOTECH Protein tyrosine kinase enzyme inhibitors
Dec, 2030

(4 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).
US8790708 PUMA BIOTECH Coated tablet formulations and uses thereof
Nov, 2030

(4 years from now)

US9211291 PUMA BIOTECH Treatment regimen utilizing neratinib for breast cancer
Mar, 2030

(4 years from now)

US9265784 PUMA BIOTECH Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Aug, 2029

(3 years from now)

US8669273 PUMA BIOTECH Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Jul, 2031

(5 years from now)

US8518446 PUMA BIOTECH Coated tablet formulations and uses thereof
Nov, 2030

(4 years from now)

US9630946 PUMA BIOTECH Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Oct, 2028

(2 years from now)

US9139558 PUMA BIOTECH Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Oct, 2028

(2 years from now)

US7982043 PUMA BIOTECH Protein tyrosine kinase enzyme inhibitors
Oct, 2025

(3 months ago)

US10035788 PUMA BIOTECH Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Oct, 2028

(2 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 17, 2022
New Indication(I-823) Feb 25, 2023
New Dosing Schedule(D-182) Jun 28, 2024

Drugs and Companies using NERATINIB MALEATE ingredient

NCE-1 date: 17 July, 2021

Market Authorisation Date: 17 July, 2017

Dosage: TABLET

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

NERLYNX family patents

Family Patents

2. 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

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3. 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

4. Tykerb patent expiration

Treatment: Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress her2 and who have received prior therapy including anthracycline, a taxane and trastuzumab

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