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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8460704 | Extended release formulation of nevirapine |
Mar, 2029
(3 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 Viramune Xr's patents.
Latest Legal Activities on Viramune Xr's Patents
Given below is the list of recent legal activities going on the following patents of Viramune Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Sep, 2020 | US8460704 |
| Post Issue Communication - Certificate of Correction | 05 Feb, 2015 | US8460704 |
| Email Notification Critical | 13 Sep, 2014 | US8460704 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Allowance | 10 Sep, 2014 | US8460704 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Allowance | 09 Sep, 2014 | US8460704 |
| Adjustment of PTA Calculation by PTO | 05 Sep, 2014 | US8460704 |
| Petition Entered | 14 Jun, 2013 | US8460704 |
| Recordation of Patent Grant Mailed Critical | 11 Jun, 2013 | US8460704 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Jun, 2013 | US8460704 |
| Email Notification Critical | 23 May, 2013 | US8460704 |
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 |
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 |
|---|---|---|---|
 | |||
| 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
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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 Generic API suppliers:
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.
Approval 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 | Discontinued | ORAL |