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
(13 years from now) | Active |
| US7713947 | Cladribine regimen for treating multiple sclerosis |
Oct, 2026
(11 months from now) | Active |
| US8377903 | Cladribine regimen for treating multiple sclerosis |
May, 2026
(7 months from now) | Active |
| US8785415 | Oral formulations of cladribine |
Apr, 2024
(1 year, 6 months ago) |
Expired
|
| US7888328 | Oral formulations of cladribine |
Apr, 2024
(1 year, 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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 May, 2024 | US10849919 |
| Request for Trial Granted
Critical | 20 Dec, 2023 | US8377903 |
| Request for Trial Granted
Critical | 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
Critical | 22 Sep, 2023 | US7713947 |
| Request for Trial Granted
Critical | 22 Sep, 2023 | US8377903 |
| Termination or Final Written Decision | 16 Aug, 2023 | US10849919 |
| Electronic Review
Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7713947 | October, 2022 |
Final Written Decision - Appealed
(18 Dec, 2024) | Merck Serono SA | TWi Pharmaceuticals, Inc. |
| US8377903 | October, 2022 |
Final Written Decision - Appealed
(18 Dec, 2024) | Merck Serono SA | TWi Pharmaceuticals, Inc. |
| US7713947 | January, 2023 |
Final Written Decision - Appealed
(18 Sep, 2024) | Merck Serono SA | Hopewell Pharma Ventures, Inc. et al. |
| US8377903 | January, 2023 |
Final Written Decision - Appealed
(18 Sep, 2024) | Merck Serono SA | Hopewell Pharma Ventures, Inc. et al. |
| 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |