Xalkori Patent Expiration

Xalkori is a drug owned by Pf Prism Cv. It is protected by 5 US drug patents filed from 2013 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 06, 2029. Details of Xalkori's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8785632 Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Mar, 2025

(7 months from now)

Active
US7230098 Aminoheteroaryl compounds as protein kinase inhibitors
Aug, 2025

(1 year, 1 month from now)

Active
US7858643 Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Oct, 2029

(5 years from now)

Active
US8217057 Polymorphs of a c-MET/HGFR inhibitor
Nov, 2029

(5 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7825137 Method of treating abnormal cell growth
May, 2027

(2 years from now)

Active


FDA has granted several exclusivities to Xalkori. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xalkori, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xalkori.

Exclusivity Information

Xalkori holds 9 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Xalkori's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 26, 2016
Orphan Drug Exclusivity(ODE-15) Aug 26, 2018
Orphan Drug Exclusivity(ODE) Aug 26, 2018
M(M-163) Sep 14, 2018
Orphan Drug Exclusivity(ODE-111) Mar 11, 2023
New Indication(I-852) Jan 14, 2024
New Indication(I-897) Jul 14, 2025
Orphan Drug Exclusivity(ODE-328) Jan 14, 2028
Orphan Drug Exclusivity(ODE-407) Jul 14, 2029

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US patents provide insights into the exclusivity only within the United States, but Xalkori is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xalkori's family patents as well as insights into ongoing legal events on those patents.

Xalkori's family patents

Xalkori has patent protection in a total of 49 countries. It's US patent count contributes only to 11.0% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Xalkori.

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Generic Launch

Generic Release Date:

Xalkori's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 06, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Xalkori Generics:

There are no approved generic versions for Xalkori as of now.





About Xalkori

Xalkori is a drug owned by Pf Prism Cv. It is used for treating ALK-positive inflammatory myofibroblastic tumors, metastatic non-small cell lung cancer, and relapsed or refractory systemic anaplastic large cell lymphoma in pediatric and young adult patients over 1 year of age. Xalkori uses Crizotinib as an active ingredient. Xalkori was launched by Pf Prism Cv in 2011.

Market Authorisation Date:

Xalkori was approved by FDA for market use on 26 August, 2011.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Xalkori is 26 August, 2011, its NCE-1 date is estimated to be 27 August, 2015

Active Ingredient:

Xalkori uses Crizotinib as the active ingredient. Check out other Drugs and Companies using Crizotinib ingredient

Treatment:

Xalkori is used for treating ALK-positive inflammatory myofibroblastic tumors, metastatic non-small cell lung cancer, and relapsed or refractory systemic anaplastic large cell lymphoma in pediatric and young adult patients over 1 year of age.

Dosage:

Xalkori is available in the following dosage forms - capsule form for oral use, capsule, pellets form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG CAPSULE Prescription ORAL
250MG CAPSULE Prescription ORAL
50MG CAPSULE, PELLETS Prescription ORAL
20MG CAPSULE, PELLETS Prescription ORAL
150MG CAPSULE, PELLETS Prescription ORAL