Cladribine Patent Expiration

Cladribine is used for treating multiple sclerosis (MS) with oral cladribine. It was first introduced by Janssen Pharmaceuticals Inc in its drug Leustatin on Feb 26, 1993. Another drug containing Cladribine is Mavenclad. 6 different companies have introduced drugs containing Cladribine.


Cladribine Patents

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

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Mavenclad US10849919 Cladribine regimen for treating progressive forms of multiple sclerosis Nov 23, 2038 Emd Serono Inc
Mavenclad US7713947 Cladribine regimen for treating multiple sclerosis Oct 16, 2026 Emd Serono Inc
Mavenclad US8377903 Cladribine regimen for treating multiple sclerosis May 31, 2026 Emd Serono Inc
Mavenclad US7888328 Oral formulations of cladribine Apr 11, 2024

(Expired)

Emd Serono Inc
Mavenclad US8785415 Oral formulations of cladribine Apr 11, 2024

(Expired)

Emd Serono Inc



Cladribine's Family Patents

Family Patents

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Cladribine Generic API Manufacturers

Several generic applications have been filed for Cladribine. The first generic version for Cladribine was by Hikma Pharmaceuticals Usa Inc and was approved on Feb 28, 2000. And the latest generic version is by Hisun Pharmaceutical (Hangzhou) Co Ltd and was approved on Nov 25, 2019.

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


Cladribine News

BioNxt (BNXT.C) surges after European Patent Office supports Cladribine thin-film - Equity.Guru

08 Aug, 2025

From Certifications to Legal Proceedings: Legal Disputes Over Second Medical Use Patents - Mondaq

28 Apr, 2025

BioNxt progresses with patent applications for innovative drug delivery technology - from WebDisclosure

29 Oct, 2024

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