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.

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.

Latest Legal Activities on Mavenclad's Patents

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

Event	Date	Patent/Publication
Critical Events This Week
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 has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 14, 2022, against patent number US8377903. The petitioner TWi Pharmaceuticals, Inc., challenged the validity or infringement of this patent, with Merck Serono SA as the respondent. Click below to track the latest information on how companies are challenging Mavenclad's patents.

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
Live updates
US10849919	February, 2023	Terminated-Settled	Ares Trading SA	Hopewell Pharma Ventures, Inc. et al.
US7713947	January, 2023	PO preliminary response filed	Merck Serono SA	Hopewell Pharma Ventures, Inc. et al.
US8377903	January, 2023	PO preliminary response filed	Merck Serono SA	Hopewell Pharma Ventures, Inc. et al.
US7713947	October, 2022	Institution Denied	Merck Serono SA	TWi Pharmaceuticals, Inc.
US8377903	October, 2022	Institution Denied	Merck Serono SA	TWi Pharmaceuticals, Inc.

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.

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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
Live updates
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.

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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.