Prefest is a drug owned by Teva Womens Health 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 Mar 30, 2020. Details of Prefest'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). | |||
| US7320970 | Low dose estrogen interrupted hormone replacement therapy |
Mar, 2020
(5 years ago) |
Expired
|
| US6747019 | Low dose estrogen interrupted hormone replacement therapy |
Mar, 2020
(5 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 Prefest's patents.
Latest Legal Activities on Prefest's Patents
Given below is the list of recent legal activities going on the following patents of Prefest.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 24 Feb, 2020 | US7320970 |
| Maintenance Fee Reminder Mailed
Critical | 09 Sep, 2019 | US7320970 |
| Patent Issue Date Used in PTA Calculation
Critical | 22 Jan, 2008 | US7320970 |
| Recordation of Patent Grant Mailed
Critical | 22 Jan, 2008 | US7320970 |
| Issue Notification Mailed
Critical | 02 Jan, 2008 | US7320970 |
| Dispatch to FDC | 18 Dec, 2007 | US7320970 |
| Application Is Considered Ready for Issue
Critical | 06 Dec, 2007 | US7320970 |
| Issue Fee Payment Verified
Critical | 27 Nov, 2007 | US7320970 |
| Issue Fee Payment Received
Critical | 27 Nov, 2007 | US7320970 |
| Mail Notice of Allowance
Critical | 27 Aug, 2007 | US7320970 |
US patents provide insights into the exclusivity only within the United States, but
Prefest 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 Prefest's family patents as well as insights into
ongoing legal events
on those patents.
Prefest's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prefest's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 30, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prefest Generic API suppliers:
Estradiol; Norgestimate is the generic name for the brand Prefest. 1 company has already filed for the generic of Prefest. Check out the entire list of companies who have already received approval for Prefest's generic
How can I launch a generic of Prefest before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prefest's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prefest'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 Prefest -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg; 1 mg and 0.09 mg |
Alternative Brands for Prefest
Prefest which is used for managing menopausal symptoms and preventing osteoporosis in women with a uterus., has several other brand drugs using the same active ingredient (Estradiol; Norgestimate). 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 | |
|---|---|---|
| Janssen Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Estradiol; Norgestimate, Prefest's active ingredient. Check the complete list of approved generic manufacturers for Prefest
About Prefest
Prefest is a drug owned by Teva Womens Health Inc. It is used for managing menopausal symptoms and preventing osteoporosis in women with a uterus. Prefest uses Estradiol; Norgestimate as an active ingredient. Prefest was launched by Teva Womens in 1999.
Approval Date:
Prefest was approved by FDA for market use on 22 October, 1999.
Active Ingredient:
Prefest uses Estradiol; Norgestimate as the active ingredient. Check out other Drugs and Companies using Estradiol; Norgestimate ingredient
Treatment:
Prefest is used for managing menopausal symptoms and preventing osteoporosis in women with a uterus.
Dosage:
Prefest is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |