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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7018992 | Hormone composition |
Sep, 2022
(4 years ago) |
Expired
|
| US5860946 | Instrument for inserting a suppository |
Jul, 2017
(9 years 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation
Critical | 28 Mar, 2006 | US7018992 |
| Recordation of Patent Grant Mailed
Critical | 28 Mar, 2006 | US7018992 |
| Issue Notification Mailed
Critical | 08 Mar, 2006 | US7018992 |
| Receipt into Pubs | 23 Feb, 2006 | US7018992 |
| Dispatch to FDC | 22 Feb, 2006 | US7018992 |
| Application Is Considered Ready for Issue
Critical | 22 Feb, 2006 | US7018992 |
| Receipt into Pubs | 20 Jan, 2006 | US7018992 |
| Printer Rush- No mailing | 27 Sep, 2005 | US7018992 |
| Pubs Case Remand to TC
Critical | 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 LĂ©on 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 LĂ©on 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Vagifem:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
Estradiol is the generic name for the brand Vagifem. 26 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 02 Jan, 2013 | 17 Sep, 2022 | Eligible | 29 May, 2015 | Less |
Alternative Brands for Vagifem
Vagifem which is used for treating atrophic vaginitis due to menopause., has several other brand drugs using the same active ingredient (Estradiol). 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.
| Drug Owner | Drug Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| ||||||||
| Agile |
| ||||||||
| Apil |
| ||||||||
| Avion Pharms |
| ||||||||
| Bayer Hlthcare |
| ||||||||
| Exeltis Usa Inc |
| ||||||||
| Janssen Pharms |
| ||||||||
| Mayne Pharma |
| ||||||||
| Millicent Mfg Pr |
| ||||||||
| Noven |
| ||||||||
| Noven Pharms Inc |
| ||||||||
| Organon Usa Organon |
| ||||||||
| Padagis Us |
| ||||||||
| Sandoz |
| ||||||||
| Sumitomo Pharma Am |
| ||||||||
| Teva Branded Pharm |
| ||||||||
| Teva Womens |
| ||||||||
| Viatris |
| ||||||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Estradiol, Vagifem's active ingredient. Check the complete list of approved generic manufacturers for Vagifem
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 in 2009.
Approval 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 |