Ceritinib Patent Expiration

Ceritinib is Used for treating cancers mediated by anaplastic lymphoma kinase (ALK). It was first introduced by Novartis Pharmaceuticals Corp in its drug Zykadia on Apr 29, 2014.


Ceritinib Patents

Given below is the list of patents protecting Ceritinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zykadia US12357630 Ceritinib Formulation Dec 13, 2037 Novartis
Zykadia US8703787 Methods of using ALK inhibitors Feb 02, 2032 Novartis
Zykadia 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 18, 2032 Novartis
Zykadia US8039474 2,3,4,9-tetrahydro-1H-carbazole derivatives as CRTH2 receptor antagonists Jun 29, 2030 Novartis
Zykadia US8039479 Compounds and compositions as protein kinase inhibitors Jun 29, 2030 Novartis
Zykadia US7964592 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Apr 29, 2028 Novartis
Zykadia US8377921 Compounds and compositions as protein kinase inhibitors Nov 20, 2027 Novartis
Zykadia US8399450 Compounds and compositions as protein kinase inhibitors Nov 20, 2027 Novartis
Zykadia US7893074 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Apr 25, 2026

(Expired)

Novartis
Zykadia US8188276 2,4-pyrimidinediamine compounds and their uses Jan 31, 2023

(Expired)

Novartis
Zykadia US8835430 2,4-pyrimidinediamine compounds and their uses Jan 31, 2023

(Expired)

Novartis
Zykadia US9018204 2,4-pyrimidinediamine compounds and their uses Jan 31, 2023

(Expired)

Novartis
Zykadia US9416112 2,4-pyrimidinediamine compounds and their uses Jan 31, 2023

(Expired)

Novartis
Zykadia US7153964 Pyrimidine compounds Feb 26, 2021

(Expired)

Novartis



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 Ceritinib's patents.

Given below is the list recent legal activities going on the following patents of Ceritinib.

Activity Date Patent Number
Patent litigations
Expire Patent 23 Sep, 2024 US9416112
Payment of Maintenance Fee, 12th Year, Large Entity 04 Sep, 2024 US8399450
Payment of Maintenance Fee, 12th Year, Large Entity 07 Aug, 2024 US8377921
Expire Patent 01 Jul, 2024 US8188276(Litigated)
Maintenance Fee Reminder Mailed 08 Apr, 2024 US9416112
Email Notification 15 Feb, 2024 US8188276(Litigated)
Change in Power of Attorney (May Include Associate POA) 15 Feb, 2024 US8188276(Litigated)
Change in Power of Attorney (May Include Associate POA) 14 Feb, 2024 US9416112
Email Notification 14 Feb, 2024 US9416112
Change in Power of Attorney (May Include Associate POA) 13 Feb, 2024 US8835430(Litigated)


Ceritinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Ceritinib:

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.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Giselle Sholler NA RECRUITING
(Sep 1, 2026)
PHASE2
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Molecular Profiling of Advanced Soft-tissue Sarcomas Institut National de la Santé Et de la Recherche Médicale, France NA COMPLETED
(Apr 1, 2026)
PHASE3
Next Generation Personalized Neuroblastoma Therapy Yael P Mosse NA TERMINATED
(Mar 1, 2026)
PHASE1


Ceritinib Generic API Manufacturers

Given below is the list of companies who have filed for Ceritinib generic, along with the locations of their manufacturing plants worldwide.