Viramune Xr Patent Expiration

Viramune Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 12, 2029. Details of Viramune Xr'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8460704 Extended release formulation of nevirapine
Mar, 2029

(4 years from now)

Active


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

Exclusivity Information

Viramune Xr holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Viramune Xr's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Mar 25, 2014
New Patient Population(NPP) Nov 08, 2015

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

Viramune Xr's oppositions filed in EPO

Viramune Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 23, 2016, by Frkelly. This opposition was filed on patent number EP08756672A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08756672A Dec, 2016 FRKelly Revoked


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

Viramune Xr's family patents

Viramune Xr has patent protection in a total of 27 countries. It's US patent count contributes only to 10.0% of its total global patent coverage. 12 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 Viramune Xr.

Family Patents

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Generic Launch

Generic Release Date:

Viramune Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 12, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Viramune Xr Generics:

Nevirapine is the generic name for the brand Viramune Xr. 16 different companies have already filed for the generic of Viramune Xr, with Tech Organized having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Viramune Xr's generic

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

You can seek FDA approval to launch a generic drug before the expiration of Viramune Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Viramune Xr'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 Viramune Xr -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
400 mg 21 Jun, 2013 3 03 Apr, 2014 12 Mar, 2029 Eligible




About Viramune Xr

Viramune Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for managing HIV-1 infection through once-daily administration. Viramune Xr uses Nevirapine as an active ingredient. Viramune Xr was launched by Boehringer Ingelheim in 2012.

Market Authorisation Date:

Viramune Xr was approved by FDA for market use on 08 November, 2012.

Active Ingredient:

Viramune Xr uses Nevirapine as the active ingredient. Check out other Drugs and Companies using Nevirapine ingredient

Treatment:

Viramune Xr is used for managing HIV-1 infection through once-daily administration.

Dosage:

Viramune Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
400MG TABLET, EXTENDED RELEASE Prescription ORAL