Xalkori is a drug owned by Pf Prism Cv. It is protected by 5 US drug patents filed from 2013 to 2023. Out of these, 3 drug patents are active and 2 have expired. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8217057 | Polymorphs of a c-MET/HGFR inhibitor |
Nov, 2029
(3 years from now) | Active |
| US7858643 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
Oct, 2029
(3 years from now) | Active |
| US7230098 | Aminoheteroaryl compounds as protein kinase inhibitors |
Aug, 2025
(1 year, 1 month ago) |
Expired
|
| US8785632 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
Mar, 2025
(1 year, 7 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7825137 | Method of treating abnormal cell growth |
May, 2027
(7 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Xalkori's patents.
Latest Legal Activities on Xalkori's Patents
Given below is the list of recent legal activities going on the following patents of Xalkori.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 09 Mar, 2026 | US8785632 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2023 | US8217057 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 May, 2022 | US7858643 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2022 | US7825137 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Dec, 2021 | US8785632 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Dec, 2019 | US8217057 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Nov, 2018 | US7230098 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 May, 2018 | US7858643 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2018 | US7825137 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Dec, 2017 | US8785632 |
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 7 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) | Aug 26, 2018 |
| Orphan Drug Exclusivity(ODE-15) | 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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Xalkori:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 2023.
Approval Date:
Xalkori was approved by FDA for market use on 07 September, 2023.
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 |
|---|---|---|---|
| 20MG | CAPSULE, PELLETS | Prescription | ORAL |
| 150MG | CAPSULE, PELLETS | Prescription | ORAL |
| 250MG | CAPSULE | Prescription | ORAL |
| 200MG | CAPSULE | Prescription | ORAL |
| 50MG | CAPSULE, PELLETS | Prescription | ORAL |