Lo Loestrin Fe Patent Expiration

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

(4 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.

Given below is the list of recent legal activities going on the following patents of Lo Loestrin Fe.

Activity Date Patent Number
Patent litigations
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 27 Apr, 2010 US7704984 (Litigated)
Patent Issue Date Used in PTA Calculation 27 Apr, 2010 US7704984 (Litigated)
Issue Notification Mailed 07 Apr, 2010 US7704984 (Litigated)
Dispatch to FDC 15 Mar, 2010 US7704984 (Litigated)
Application Is Considered Ready for Issue 12 Mar, 2010 US7704984 (Litigated)
Issue Fee Payment Verified 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.

Last updated on November 12, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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

Lo Loestrin Fe has patent protection in a total of 7 countries. It's US patent count contributes only to 27.3% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Lo Loestrin Fe.

Family Patents

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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. 15 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
Lo Minastrin Fe
Minastrin 24 Fe
Taytulla
Teva Branded Pharm
Loestrin 24 Fe


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