Loseasonique is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 05, 2028. Details of Loseasonique'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). | |||
| US7855190 | Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration |
Dec, 2028
(3 years from now) | Active |
| US7858605 | Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology |
Jun, 2023
(1 year, 10 months ago) |
Expired
|
| US7615545 | Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology |
Jun, 2023
(1 year, 10 months 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 Loseasonique's patents.
Latest Legal Activities on Loseasonique's Patents
Given below is the list of recent legal activities going on the following patents of Loseasonique.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 30 Jan, 2023 | US7858605 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 15 Aug, 2022 | US7858605 (Litigated) |
| Expire Patent Critical | 13 Dec, 2021 | US7615545 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 28 Jun, 2021 | US7615545 (Litigated) |
| Expire Patent Critical | 28 Jan, 2019 | US7855190 |
| Maintenance Fee Reminder Mailed Critical | 06 Aug, 2018 | US7855190 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jun, 2018 | US7858605 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 28 Dec, 2010 | US7858605 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 Dec, 2010 | US7858605 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 21 Dec, 2010 | US7855190 |
FDA has granted several exclusivities to Loseasonique. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Loseasonique, 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 Loseasonique.
Exclusivity Information
Loseasonique holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Loseasonique's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 24, 2011 |
Several oppositions have been filed on Loseasonique's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Loseasonique's generic, the next section provides detailed information on ongoing and past EP oppositions related to Loseasonique patents.
Loseasonique's Oppositions Filed in EPO
Loseasonique has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 03, 2014, by Bröcher, Dirk Joachim. This opposition was filed on patent number EP02782404A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02782404A | Jun, 2014 | Laboratorios Léon Farma, S.A. | Revoked |
| EP02782404A | Jun, 2014 | Bröcher, Dirk Joachim | Revoked |
US patents provide insights into the exclusivity only within the United States, but Loseasonique 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 Loseasonique's family patents as well as insights into ongoing legal events on those patents.
Loseasonique's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Loseasonique's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 05, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Loseasonique Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Loseasonique. 16 different companies have already filed for the generic of Loseasonique, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Loseasonique's generic
How can I launch a generic of Loseasonique before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Loseasonique's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Loseasonique'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 Loseasonique -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg/0.02 mg and 0.01 mg | 16 Nov, 2009 | 1 | 26 Oct, 2011 | 15 Jun, 2023 | Eligible |
Alternative Brands for Loseasonique
Loseasonique which is used for contraceptive purposes., has several other brand drugs in the same treatment category and using the same active ingredient (Ethinyl Estradiol; Levonorgestrel). 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; Levonorgestrel. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Agile |
| |
| Avion Pharms |
| |
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Levonorgestrel, Loseasonique's active ingredient. Check the complete list of approved generic manufacturers for Loseasonique
About Loseasonique
Loseasonique is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for contraceptive purposes. Loseasonique uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Loseasonique was launched by Teva Branded Pharm in 2008.
Approval Date:
Loseasonique was approved by FDA for market use on 24 October, 2008.
Active Ingredient:
Loseasonique uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Loseasonique is used for contraceptive purposes.
Dosage:
Loseasonique is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.02MG,0.1MG;0.01MG,N/A | TABLET | Prescription | ORAL |