Vumerity Patent Expiration

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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8669281 Prodrugs of fumarates and their use in treating various diseases
Sep, 2033

(9 years from now)

Active
US10080733 Prodrugs of fumarates and their use in treating various diseases
Sep, 2033

(9 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9090558 Prodrugs of fumarates and their use in treating various diseases
Sep, 2033

(9 years from now)

Active

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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
Patent litigations
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

Vumerity has patent protection in a total of 25 countries. It's US patent count contributes only to 30.0% of its total global patent coverage. Click below to unlock the full patent family tree for Vumerity.

Family Patents

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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




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.

Market Authorisation 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