Vagifem is a drug owned by Novo Nordisk Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2022. Details of Vagifem'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). | |||
| US5860946 | Instrument for inserting a suppository |
Jul, 2017
(7 years ago) |
Expired
|
| US7018992 | Hormone composition |
Sep, 2022
(1 year, 10 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 Vagifem's patents.
Latest Legal Activities on Vagifem's Patents
Given below is the list of recent legal activities going on the following patents of Vagifem.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 28 Mar, 2006 | US7018992 |
| Recordation of Patent Grant Mailed | 28 Mar, 2006 | US7018992 |
| Issue Notification Mailed | 08 Mar, 2006 | US7018992 |
| Receipt into Pubs | 23 Feb, 2006 | US7018992 |
| Dispatch to FDC | 22 Feb, 2006 | US7018992 |
| Application Is Considered Ready for Issue | 22 Feb, 2006 | US7018992 |
| Receipt into Pubs | 20 Jan, 2006 | US7018992 |
| Printer Rush- No mailing | 27 Sep, 2005 | US7018992 |
| Pubs Case Remand to TC | 06 Sep, 2005 | US7018992 |
| Workflow - File Sent to Contractor | 03 Jun, 2005 | US7018992 |
FDA has granted several exclusivities to Vagifem. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vagifem, 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 Vagifem.
Exclusivity Information
Vagifem holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Vagifem's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-122) | Nov 25, 2012 |
Several oppositions have been filed on Vagifem'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 Vagifem's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vagifem patents.
Vagifem's oppositions filed in EPO
Vagifem has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 01, 2012, by Laboratorios Léon Farma, S.A.. This opposition was filed on patent number EP01270333A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP01270333A | Aug, 2012 | Helm AG | Revoked |
| EP01270333A | Aug, 2012 | Laboratorios Léon Farma, S.A. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Vagifem 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 Vagifem's family patents as well as insights into ongoing legal events on those patents.
Vagifem's family patents
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Generic Launch
Generic Release Date:
Vagifem's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 17, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vagifem Generics:
Estradiol is the generic name for the brand Vagifem. 22 different companies have already filed for the generic of Vagifem, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vagifem's generic
How can I launch a generic of Vagifem before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vagifem's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vagifem'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 Vagifem -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mcg | 02 Jan, 2013 | 1 | 29 May, 2015 | 17 Sep, 2022 | Eligible |
About Vagifem
Vagifem is a drug owned by Novo Nordisk Inc. It is used for treating atrophic vaginitis due to menopause. Vagifem uses Estradiol as an active ingredient. Vagifem was launched by Novo Nordisk Inc in 2009.
Market Authorisation Date:
Vagifem was approved by FDA for market use on 25 November, 2009.
Active Ingredient:
Vagifem uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient
Treatment:
Vagifem is used for treating atrophic vaginitis due to menopause.
Dosage:
Vagifem is available in tablet form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MCG | TABLET | Prescription | VAGINAL |