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Afinitor patents expiration

AFINITOR's oppositions filed in EPO
AFINITOR Litigations
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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5665772 NOVARTIS O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
Sep, 2019

(4 years ago)

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

(7 years ago)

US6004973

(Pediatric)

NOVARTIS Pharmaceutical compositions comprising rafamycin coprecipitates
Jan, 2017

(7 years ago)

US7297703 NOVARTIS Macrolides
Dec, 2019

(4 years ago)

US7741338 NOVARTIS Macrolides
Dec, 2019

(4 years ago)

US5665772

(Pediatric)

NOVARTIS O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
Mar, 2020

(4 years ago)

US7297703

(Pediatric)

NOVARTIS Macrolides
Jun, 2020

(3 years ago)

US8778962 NOVARTIS Treatment of solid tumors with rapamycin derivatives
Feb, 2022

(2 years ago)

US8436010 NOVARTIS Treatment of solid tumors with rapamycin derivatives
Feb, 2022

(2 years ago)

US8778962

(Pediatric)

NOVARTIS Treatment of solid tumors with rapamycin derivatives
Aug, 2022

(1 year, 8 months ago)

US8436010

(Pediatric)

NOVARTIS Treatment of solid tumors with rapamycin derivatives
Aug, 2022

(1 year, 8 months ago)

US8410131 NOVARTIS Cancer treatment
Nov, 2025

(1 year, 6 months from now)

US8410131

(Pediatric)

NOVARTIS Cancer treatment
May, 2026

(2 years from now)

US9006224 NOVARTIS Neuroendocrine tumor treatment
Jul, 2028

(4 years from now)

Afinitor is owned by Novartis.

Afinitor contains Everolimus.

Afinitor has a total of 14 drug patents out of which 11 drug patents have expired.

Expired drug patents of Afinitor are:

  • US6004973
  • US6004973*PED
  • US7297703
  • US7741338
  • US5665772*PED
  • US7297703*PED
  • US8778962
  • US8436010
  • US8778962*PED
  • US8436010*PED
  • US5665772

Afinitor was authorised for market use on 09 July, 2010.

Afinitor is available in tablet;oral dosage forms.

Afinitor can be used as treatment of patients with progressive neuroendocrine tumors of pancreatic origin (pnet) that are unresectable, locally advanced or metastatic, 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 advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole, treatment of solid excretory system tumors; advanced renal cell carcinoma (rcc), after failure of treatment with sunitinib or sorafenib.

Drug patent challenges can be filed against Afinitor from 26 October, 2014.

The generics of Afinitor are possible to be released after 01 July, 2028.

Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-724) Feb 26, 2019
Orphan Drug Exclusivity(ODE-108) Feb 26, 2023
Orphan Drug Exclusivity(ODE-24) Apr 26, 2019
Orphan Drug Exclusivity(ODE-11) May 05, 2018
New Chemical Entity Exclusivity(NCE) Mar 30, 2014
New Indication(I-630) Oct 29, 2013
New Indication(I-655) Jul 20, 2015
New Indication(I-650) Apr 26, 2015
Orphan Drug Exclusivity(ODE) Apr 26, 2019
Pediatric Exclusivity(PED) Oct 26, 2015
New Indication(I-638) May 05, 2014

Drugs and Companies using EVEROLIMUS ingredient

NCE-1 date: 26 October, 2014

Market Authorisation Date: 09 July, 2010

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 ...

Dosage: TABLET;ORAL

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AFINITOR family patents

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