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. Xalkori's patents have been open to challenges since 27 August, 2015. 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
(4 years from now) | Active |
| US7858643 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
Oct, 2029
(4 years from now) | Active |
| US7230098 | Aminoheteroaryl compounds as protein kinase inhibitors |
Aug, 2025
(8 months from now) | Active |
| US8785632 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
Mar, 2025
(2 months from now) | Active |
| 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
(2 years 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 |
|---|---|---|
 | ||
| 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 |
| Email Notification Critical | 28 Apr, 2016 | US7230098 |
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) | 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
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.
Approval Date:
Xalkori was approved by FDA for market use on 26 August, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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, pellets form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG | CAPSULE | Prescription | ORAL |
| 200MG | CAPSULE | Prescription | ORAL |
| 50MG | CAPSULE, PELLETS | Prescription | ORAL |
| 150MG | CAPSULE, PELLETS | Prescription | ORAL |
| 20MG | CAPSULE, PELLETS | Prescription | ORAL |