Zykadia is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 13 US drug patents filed from 2014 to 2019. Out of these, 8 drug patents are active and 5 have expired. Zykadia's patents have been open to challenges since 29 April, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2032. Details of Zykadia'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. | |||
| US9309229 | Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine |
Jan, 2032
(7 years from now) | Active |
| US8039479 | Compounds and compositions as protein kinase inhibitors |
Jun, 2030
(5 years from now) | Active |
| US8039474 | 2,3,4,9-tetrahydro-1H-carbazole derivatives as CRTH2 receptor antagonists |
Jun, 2030
(5 years from now) | Active |
| US7964592 | 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders |
Apr, 2028
(3 years from now) | Active |
| US8399450 | Compounds and compositions as protein kinase inhibitors |
Nov, 2027
(2 years from now) | Active |
| US7893074 | 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders |
Apr, 2026
(1 year, 3 months from now) | Active |
| US9416112 | 2,4-pyrimidinediamine compounds and their uses |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US8188276 | 2,4-pyrimidinediamine compounds and their uses |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US8835430 | 2,4-pyrimidinediamine compounds and their uses |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US9018204 | 2,4-pyrimidinediamine compounds and their uses |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US7153964 | Pyrimidine compounds |
Feb, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8703787 | Methods of using ALK inhibitors |
Feb, 2032
(7 years from now) | Active |
| US8377921 | Compounds and compositions as protein kinase inhibitors |
Nov, 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 Zykadia's patents.
Latest Legal Activities on Zykadia's Patents
Given below is the list of recent legal activities going on the following patents of Zykadia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Jul, 2024 | US8188276 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Apr, 2024 | US9416112 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 Feb, 2024 | US8188276 (Litigated) |
| Email Notification Critical | 15 Feb, 2024 | US8188276 (Litigated) |
| Email Notification Critical | 14 Feb, 2024 | US9416112 |
| Change in Power of Attorney (May Include Associate POA) Critical | 14 Feb, 2024 | US9416112 |
| Email Notification Critical | 13 Feb, 2024 | US8835430 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Feb, 2024 | US8835430 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 15 Jan, 2024 | US8188276 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Sep, 2023 | US9309229 |
FDA has granted several exclusivities to Zykadia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zykadia, 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 Zykadia.
Exclusivity Information
Zykadia holds 6 exclusivities. All of its exclusivities have expired in 2024. Details of Zykadia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 29, 2019 |
| M(M-199) | May 26, 2020 |
| Orphan Drug Exclusivity(ODE-66) | Apr 29, 2021 |
| Orphan Drug Exclusivity(ODE) | May 26, 2024 |
| ODE*(ODE*) | May 26, 2024 |
| Orphan Drug Exclusivity(ODE-145) | May 26, 2024 |
Several oppositions have been filed on Zykadia's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zykadia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zykadia patents.
Zykadia's Oppositions Filed in EPO
Zykadia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 08, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP12703670A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16167355A | May, 2019 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
| EP16167355A | Apr, 2019 | Generics (UK) Ltd | Opposition rejected |
| EP11806079A | Apr, 2018 | Generics (UK) Ltd | Revoked |
| EP11806079A | Apr, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP12703670A | Mar, 2016 | Generics [UK] Limited | Opposition rejected |
| EP12703670A | Mar, 2016 | I P S Intellectual Property Services | Opposition rejected |
| EP12703670A | Mar, 2016 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Zykadia 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 Zykadia's family patents as well as insights into ongoing legal events on those patents.
Zykadia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zykadia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zykadia Generics:
There are no approved generic versions for Zykadia as of now.
About Zykadia
Zykadia is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating cancers mediated by anaplastic lymphoma kinase (ALK). Zykadia uses Ceritinib as an active ingredient. Zykadia was launched by Novartis in 2019.
Approval Date:
Zykadia was approved by FDA for market use on 18 March, 2019.
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 Zykadia is 18 March, 2019, its NCE-1 date is estimated to be 29 April, 2018.
Active Ingredient:
Zykadia uses Ceritinib as the active ingredient. Check out other Drugs and Companies using Ceritinib ingredient
Treatment:
Zykadia is used for treating cancers mediated by anaplastic lymphoma kinase (ALK).
Dosage:
Zykadia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |