Lybrel is a drug owned by Wyeth Pharmaceuticals 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 Sep 03, 2018. Details of Lybrel'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). | |||
| US6500814 | Hormonal contraceptive |
Sep, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Lybrel 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 Lybrel's family patents as well as insights into ongoing legal events on those patents.
Lybrel's Family Patents
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Generic Launch
Generic Release Date:
Lybrel's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 03, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lybrel Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Lybrel. 16 different companies have already filed for the generic of Lybrel, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lybrel's generic
How can I launch a generic of Lybrel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lybrel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lybrel'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 Lybrel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.09 mg/0.02 mg | 05 Oct, 2007 | 1 | 06 Jun, 2011 | Non-Forfeiture |
Alternative Brands for Lybrel
Lybrel which is used for contraception., 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 |
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| Organon |
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| Teva Branded Pharm |
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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, Lybrel's active ingredient. Check the complete list of approved generic manufacturers for Lybrel
About Lybrel
Lybrel is a drug owned by Wyeth Pharmaceuticals Inc. It is used for contraception. Lybrel uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Lybrel was launched by Wyeth Pharms Inc in 2007.
Approval Date:
Lybrel was approved by FDA for market use on 22 May, 2007.
Active Ingredient:
Lybrel uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Lybrel is used for contraception.
Dosage:
Lybrel is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |