Loestrin 24 Fe is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 22, 2014. Details of Loestrin 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). | |||
| US5552394 | Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy |
Jul, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Loestrin 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 Loestrin 24 Fe's family patents as well as insights into ongoing legal events on those patents.
Loestrin 24 Fe's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Loestrin 24 Fe's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 22, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Loestrin 24 Fe Generic API suppliers:
Ethinyl Estradiol; Norethindrone Acetate is the generic name for the brand Loestrin 24 Fe. 15 different companies have already filed for the generic of Loestrin 24 Fe, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Loestrin 24 Fe's generic
How can I launch a generic of Loestrin 24 Fe before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Loestrin 24 Fe's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Loestrin 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 Loestrin 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 | 17 Apr, 2006 | 1 | 01 Sep, 2009 | 22 Jul, 2014 | Extinguished |
Alternative Brands for Loestrin 24 Fe
Loestrin 24 Fe which is used for preventing pregnancy., 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, Loestrin 24 Fe's active ingredient. Check the complete list of approved generic manufacturers for Loestrin 24 Fe
About Loestrin 24 Fe
Loestrin 24 Fe is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for preventing pregnancy. Loestrin 24 Fe uses Ethinyl Estradiol; Norethindrone Acetate as an active ingredient. Loestrin 24 Fe was launched by Teva Branded Pharm in 2006.
Approval Date:
Loestrin 24 Fe was approved by FDA for market use on 17 February, 2006.
Active Ingredient:
Loestrin 24 Fe uses Ethinyl Estradiol; Norethindrone Acetate as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Norethindrone Acetate ingredient
Treatment:
Loestrin 24 Fe is used for preventing pregnancy.
Dosage:
Loestrin 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 |