Mavenclad Patent Expiration

Mavenclad is a drug owned by Emd Serono Inc. It is protected by 5 US drug patents filed from 2019 to 2022. 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 23, 2038. Details of Mavenclad's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10849919 Cladribine regimen for treating progressive forms of multiple sclerosis
Nov, 2038

(14 years from now)

Active
US7713947 Cladribine regimen for treating multiple sclerosis
Oct, 2026

(2 years from now)

Active
US8377903 Cladribine regimen for treating multiple sclerosis
May, 2026

(1 year, 7 months from now)

Active
US7888328 Oral formulations of cladribine
Apr, 2024

(6 months ago)

Expired
US8785415 Oral formulations of cladribine
Apr, 2024

(6 months ago)

Expired


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 Mavenclad's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 15 May, 2024 US10849919
Request for Trial Granted 20 Dec, 2023 US8377903
Request for Trial Granted 20 Dec, 2023 US7713947
Mail-Petition Decision - Denied 20 Dec, 2023 US7713947
Petition Entered 19 Dec, 2023 US7713947
Petition Decision - Denied 19 Dec, 2023 US7713947
Request for Trial Granted 22 Sep, 2023 US7713947
Request for Trial Granted 22 Sep, 2023 US8377903
Termination or Final Written Decision 16 Aug, 2023 US10849919
Electronic Review 10 May, 2023 US8377903


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Mavenclad and ongoing litigations to help you estimate the early arrival of Mavenclad generic.

Mavenclad's Litigations

Mavenclad been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 10, 2023, against patent number US10849919. The petitioner Hopewell Pharma Ventures, Inc. et al., challenged the validity of this patent, with Ares Trading SA as the respondent. Click below to track the latest information on how companies are challenging Mavenclad's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7713947 October, 2022 Trial Instituted
(20 Dec, 2023)
Merck Serono SA TWi Pharmaceuticals, Inc.
US8377903 October, 2022 Trial Instituted
(20 Dec, 2023)
Merck Serono SA TWi Pharmaceuticals, Inc.
US7713947 January, 2023 Trial Instituted
(22 Sep, 2023)
Merck Serono SA Hopewell Pharma Ventures, Inc. et al.
US8377903 January, 2023 Trial Instituted
(22 Sep, 2023)
Merck Serono SA Hopewell Pharma Ventures, Inc. et al.
US10849919 February, 2023 Terminated-Settled
(16 Aug, 2023)
Ares Trading SA Hopewell Pharma Ventures, Inc. et al.


FDA has granted some exclusivities to Mavenclad. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mavenclad, 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 Mavenclad.

Exclusivity Information

Mavenclad holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Mavenclad's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 29, 2022

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Several oppositions have been filed on Mavenclad'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 Mavenclad's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mavenclad patents.

Mavenclad's Oppositions Filed in EPO

Mavenclad has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 16, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP14001970A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP14001970A Oct, 2018 Generics (UK) Ltd Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Mavenclad 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 Mavenclad's family patents as well as insights into ongoing legal events on those patents.

Mavenclad's Family Patents

Mavenclad has patent protection in a total of 35 countries. It's US patent count contributes only to 12.1% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Mavenclad.

Family Patents

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Generic Launch

Generic Release Date:

Mavenclad's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 23, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Mavenclad Generics:

Cladribine is the generic name for the brand Mavenclad. 4 different companies have already filed for the generic of Mavenclad, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mavenclad's generic

How can I launch a generic of Mavenclad before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Mavenclad's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mavenclad's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Mavenclad -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg 07 Apr, 2022 1 16 Oct, 2026





About Mavenclad

Mavenclad is a drug owned by Emd Serono Inc. It is used for treating multiple sclerosis (MS) with oral cladribine. Mavenclad uses Cladribine as an active ingredient. Mavenclad was launched by Emd Serono Inc in 2019.

Approval Date:

Mavenclad was approved by FDA for market use on 29 March, 2019.

Active Ingredient:

Mavenclad uses Cladribine as the active ingredient. Check out other Drugs and Companies using Cladribine ingredient

Treatment:

Mavenclad is used for treating multiple sclerosis (MS) with oral cladribine.

Dosage:

Mavenclad is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG TABLET Prescription ORAL