Lo Loestrin Fe is a drug owned by Allergan Pharmaceuticals International Ltd. It is protected by 2 US drug patents filed in 2013. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2029. Details of Lo Loestrin 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). | |||
| US7704984 | Extended estrogen dosing contraceptive regimen |
Feb, 2029
(3 years from now) | Active |
| 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 Lo Loestrin Fe's patents.
Latest Legal Activities on Lo Loestrin Fe's Patents
Given below is the list of recent legal activities going on the following patents of Lo Loestrin Fe.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Sep, 2021 | US7704984 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Oct, 2017 | US7704984 (Litigated) |
| Termination or Final Written Decision | 20 Aug, 2015 | US7704984 (Litigated) |
| Petition Requesting Trial | 03 Feb, 2015 | US7704984 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 27 Apr, 2010 | US7704984 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 27 Apr, 2010 | US7704984 (Litigated) |
| Issue Notification Mailed Critical | 07 Apr, 2010 | US7704984 (Litigated) |
| Dispatch to FDC | 15 Mar, 2010 | US7704984 (Litigated) |
| Application Is Considered Ready for Issue Critical | 12 Mar, 2010 | US7704984 (Litigated) |
| Issue Fee Payment Verified Critical | 04 Mar, 2010 | US7704984 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lo Loestrin Fe and ongoing litigations to help you estimate the early arrival of Lo Loestrin Fe generic.
Lo Loestrin Fe's Litigations
Lo Loestrin Fe been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 03, 2015, against patent number US7704984. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Warner Chilcott Company, LLC as the respondent. Click below to track the latest information on how companies are challenging Lo Loestrin Fe's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7704984 | February, 2015 |
Terminated-Denied
(20 Aug, 2015) | Warner Chilcott Company, LLC | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Lo Loestrin Fe. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lo Loestrin 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 Lo Loestrin Fe.
Exclusivity Information
Lo Loestrin Fe holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Lo Loestrin Fe's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 21, 2013 |
US patents provide insights into the exclusivity only within the United States, but Lo Loestrin 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 Lo Loestrin Fe's family patents as well as insights into ongoing legal events on those patents.
Lo Loestrin Fe's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lo Loestrin Fe's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lo Loestrin Fe Generic API suppliers:
Ethinyl Estradiol; Norethindrone Acetate is the generic name for the brand Lo Loestrin Fe. 16 different companies have already filed for the generic of Lo Loestrin Fe, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lo Loestrin Fe's generic
How can I launch a generic of Lo Loestrin Fe before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lo Loestrin Fe's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lo Loestrin 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 Lo Loestrin Fe -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/0.01 mg, 0.01 mg and 75 mg | 29 Apr, 2011 | 1 | 02 Feb, 2029 | Extinguished |
Alternative Brands for Lo Loestrin Fe
Lo Loestrin Fe which is used for preventing pregnancy in women using oral contraceptives., has several other brand drugs 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 | |||
|---|---|---|---|---|
| Apil |
| |||
| Millicent Pr |
| |||
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Norethindrone Acetate, Lo Loestrin Fe's active ingredient. Check the complete list of approved generic manufacturers for Lo Loestrin Fe
About Lo Loestrin Fe
Lo Loestrin Fe is a drug owned by Allergan Pharmaceuticals International Ltd. It is used for preventing pregnancy in women using oral contraceptives. Lo Loestrin Fe uses Ethinyl Estradiol; Norethindrone Acetate as an active ingredient. Lo Loestrin Fe was launched by Apil in 2010.
Approval Date:
Lo Loestrin Fe was approved by FDA for market use on 21 October, 2010.
Active Ingredient:
Lo Loestrin Fe uses Ethinyl Estradiol; Norethindrone Acetate as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Norethindrone Acetate ingredient
Treatment:
Lo Loestrin Fe is used for preventing pregnancy in women using oral contraceptives.
Dosage:
Lo Loestrin Fe is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.01MG,0.01MG;1MG,N/A | TABLET | Prescription | ORAL |