Minastrin 24 Fe is a drug owned by Allergan Pharmaceuticals International Ltd. It is protected by 2 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2019. Details of Minastrin 24 Fe'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). | |||
| US6667050 | Chewable oral contraceptive |
Apr, 2019
(5 years ago) |
Expired
|
| US5552394 | Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy |
Jul, 2014
(10 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 Minastrin 24 Fe's patents.
Latest Legal Activities on Minastrin 24 Fe's Patents
Given below is the list of recent legal activities going on the following patents of Minastrin 24 Fe.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 20 Jan, 2016 | US6667050 (Litigated) |
| File Marked Found | 17 Dec, 2015 | US6667050 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Apr, 2010 | US6667050 (Litigated) |
| Correspondence Address Change Critical | 29 Apr, 2010 | US6667050 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 23 Dec, 2003 | US6667050 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 23 Dec, 2003 | US6667050 (Litigated) |
| Issue Notification Mailed Critical | 04 Dec, 2003 | US6667050 (Litigated) |
| Receipt into Pubs | 14 Nov, 2003 | US6667050 (Litigated) |
| Application Is Considered Ready for Issue Critical | 13 Nov, 2003 | US6667050 (Litigated) |
| Receipt into Pubs | 07 Oct, 2003 | US6667050 (Litigated) |
FDA has granted several exclusivities to Minastrin 24 Fe. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Minastrin 24 Fe, 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 Minastrin 24 Fe.
Exclusivity Information
Minastrin 24 Fe holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Minastrin 24 Fe's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | May 08, 2016 |
US patents provide insights into the exclusivity only within the United States, but Minastrin 24 Fe 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 Minastrin 24 Fe's family patents as well as insights into ongoing legal events on those patents.
Minastrin 24 Fe's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Minastrin 24 Fe's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Minastrin 24 Fe Generic API suppliers:
Ethinyl Estradiol; Norethindrone Acetate is the generic name for the brand Minastrin 24 Fe. 15 different companies have already filed for the generic of Minastrin 24 Fe, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Minastrin 24 Fe's generic
How can I launch a generic of Minastrin 24 Fe before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Minastrin 24 Fe's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Minastrin 24 Fe'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 Minastrin 24 Fe -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/0.02 mg and 75 mg | 23 Apr, 2014 | 1 | 24 May, 2016 | 06 Apr, 2019 | Eligible |
Alternative Brands for Minastrin 24 Fe
Minastrin 24 Fe which is used for contraception., has several other brand drugs in the same treatment category and using the same active ingredient (Ethinyl Estradiol; Norethindrone Acetate). 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 | Treatment Area | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil |
| |||||||||||
| Bayer Hlthcare |
| |||||||||||
| Evofem Inc |
| |||||||||||
| Organon |
| |||||||||||
| Teva Branded Pharm |
| |||||||||||
| Wyeth Pharms Inc |
| |||||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ethinyl Estradiol; Norethindrone Acetate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Apil |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Norethindrone Acetate, Minastrin 24 Fe's active ingredient. Check the complete list of approved generic manufacturers for Minastrin 24 Fe
About Minastrin 24 Fe
Minastrin 24 Fe is a drug owned by Allergan Pharmaceuticals International Ltd. It is used for contraception. Minastrin 24 Fe uses Ethinyl Estradiol; Norethindrone Acetate as an active ingredient. Minastrin 24 Fe was launched by Apil in 2013.
Approval Date:
Minastrin 24 Fe was approved by FDA for market use on 08 May, 2013.
Active Ingredient:
Minastrin 24 Fe uses Ethinyl Estradiol; Norethindrone Acetate as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Norethindrone Acetate ingredient
Treatment:
Minastrin 24 Fe is used for contraception.
Dosage:
Minastrin 24 Fe is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |