Vumerity is a drug owned by Biogen Inc. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 20, 2033. Details of Vumerity's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10080733 | Prodrugs of fumarates and their use in treating various diseases |
Sep, 2033
(8 years from now) | Active |
| US8669281 | Prodrugs of fumarates and their use in treating various diseases |
Sep, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9090558 | Prodrugs of fumarates and their use in treating various diseases |
Sep, 2033
(8 years from now) | Active |
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 Vumerity's patents.
Latest Legal Activities on Vumerity's Patents
Given below is the list of recent legal activities going on the following patents of Vumerity.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Resp. to req. for info. sent under 37 CFR 1.750 | 03 Jun, 2024 | US8669281 |
| Withdrawal of Application for PTE Critical | 01 May, 2024 | US9090558 |
| Withdrawal of Application for PTE Critical | 01 May, 2024 | US10080733 |
| Requirement for information sent under 37 CFR 1.750 | 04 Apr, 2024 | US10080733 |
| Requirement for information sent under 37 CFR 1.750 | 04 Apr, 2024 | US9090558 |
| Requirement for information sent under 37 CFR 1.750 | 04 Apr, 2024 | US8669281 |
| Notice of Final Determination -Election Required | 29 Mar, 2024 | US10080733 |
| Notice of Final Determination -Election Required | 29 Mar, 2024 | US8669281 |
| Notice of Final Determination -Election Required | 29 Mar, 2024 | US9090558 |
| FDA Final Eligibility Letter Critical | 26 Apr, 2023 | US10080733 |
Several oppositions have been filed on Vumerity'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 Vumerity's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vumerity patents.
Vumerity's Oppositions Filed in EPO
Vumerity has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 05, 2019, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP14767892A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14767892A | Mar, 2019 | Hexal AG | Granted and Under Opposition |
| EP14767892A | Mar, 2019 | Generics (UK) Ltd | Granted and Under Opposition |
| EP14767892A | Mar, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Vumerity 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 Vumerity's family patents as well as insights into ongoing legal events on those patents.
Vumerity's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vumerity's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 20, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vumerity Generics:
There are no approved generic versions for Vumerity as of now.
How can I launch a generic of Vumerity before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vumerity's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vumerity'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 Vumerity -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 231 mg | 23 Dec, 2020 | 1 | 20 Sep, 2033 |
Alternative Brands for Vumerity
Vumerity which is used for treating multiple sclerosis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Vumerity
Vumerity is a drug owned by Biogen Inc. It is used for treating multiple sclerosis. Vumerity uses Diroximel Fumarate as an active ingredient. Vumerity was launched by Biogen Inc in 2019.
Approval Date:
Vumerity was approved by FDA for market use on 29 October, 2019.
Active Ingredient:
Vumerity uses Diroximel Fumarate as the active ingredient. Check out other Drugs and Companies using Diroximel Fumarate ingredient
Treatment:
Vumerity is used for treating multiple sclerosis.
Dosage:
Vumerity is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 231MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |