Pharsight

Gilotrif patents expiration

GILOTRIF'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.
US6251912 BOEHRINGER INGELHEIM Substituted quinazoline derivatives
Jul, 2018

(5 years ago)

USRE43431 BOEHRINGER INGELHEIM Quinazoline derivatives and pharmaceutical compositions containing them
Jan, 2026

(1 year, 8 months from now)

US8426586 BOEHRINGER INGELHEIM Process for preparing amino crotonyl compounds
Oct, 2029

(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).
USRE43431

(Pediatric)

BOEHRINGER INGELHEIM Quinazoline derivatives and pharmaceutical compositions containing them
Jul, 2026

(2 years from now)

US9539258 BOEHRINGER INGELHEIM Quinazoline derivatives for the treatment of cancer diseases
Nov, 2026

(2 years from now)

US9539258

(Pediatric)

BOEHRINGER INGELHEIM Quinazoline derivatives for the treatment of cancer diseases
May, 2027

(3 years from now)

US8545884 BOEHRINGER INGELHEIM Solid pharmaceutical formulations comprising BIBW 2992
Dec, 2029

(5 years from now)

US8426586

(Pediatric)

BOEHRINGER INGELHEIM Process for preparing amino crotonyl compounds
Apr, 2030

(5 years from now)

US8545884

(Pediatric)

BOEHRINGER INGELHEIM Solid pharmaceutical formulations comprising BIBW 2992
Jun, 2030

(6 years from now)

US10004743 BOEHRINGER INGELHEIM Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Jul, 2030

(6 years from now)

US10004743

(Pediatric)

BOEHRINGER INGELHEIM Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Jan, 2031

(6 years from now)

Gilotrif is owned by Boehringer Ingelheim.

Gilotrif contains Afatinib Dimaleate.

Gilotrif has a total of 11 drug patents out of which 1 drug patent has expired.

Expired drug patents of Gilotrif are:

  • US6251912

Gilotrif was authorised for market use on 12 July, 2013.

Gilotrif is available in tablet;oral dosage forms.

Gilotrif can be used as treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy, treatment of cancer.

Drug patent challenges can be filed against Gilotrif from 07 October, 2024.

The generics of Gilotrif are possible to be released after 05 January, 2031.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-230) Jan 12, 2025
M(M-276) Apr 07, 2025
Pediatric Exclusivity(PED) Oct 07, 2025
Orphan Drug Exclusivity(ODE) Apr 15, 2023
New Chemical Entity Exclusivity(NCE) Jul 12, 2018
New Indication(I-730) Apr 15, 2019
Orphan Drug Exclusivity(ODE-115) Apr 15, 2023
New Indication(I-763) Jan 12, 2021
Orphan Drug Exclusivity(ODE-50) Jul 12, 2020

Drugs and Companies using AFATINIB DIMALEATE ingredient

NCE-1 date: 07 October, 2024

Market Authorisation Date: 12 July, 2013

Treatment: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy; Treatment of cancer

Dosage: TABLET;ORAL

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

GILOTRIF family patents

Family Patents