Seasonale is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 23, 2017. Details of Seasonale'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). | |||
| USRE39861 | Methods of extended use oral contraception |
Jun, 2017
(7 years ago) |
Expired
|
| US5898032 | Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy |
Jun, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Seasonale 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 Seasonale's family patents as well as insights into ongoing legal events on those patents.
Seasonale's Family Patents
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Generic Launch
Generic Release Date:
Seasonale's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 23, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Seasonale Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Seasonale. 16 different companies have already filed for the generic of Seasonale, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Seasonale's generic
How can I launch a generic of Seasonale before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Seasonale's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Seasonale'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 Seasonale -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.15 mg/0.03 mg | 29 Mar, 2004 |
Alternative Brands for Seasonale
Seasonale which is used for contraception in women., 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 |
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| Evofem Inc |
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| Organon |
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| Teva Branded Pharm |
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| Wyeth Pharms Inc |
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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, Seasonale's active ingredient. Check the complete list of approved generic manufacturers for Seasonale
About Seasonale
Seasonale is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for contraception in women. Seasonale uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Seasonale was launched by Teva Branded Pharm in 2003.
Approval Date:
Seasonale was approved by FDA for market use on 05 September, 2003.
Active Ingredient:
Seasonale uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Seasonale is used for contraception in women.
Dosage:
Seasonale is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.03MG;0.15MG | TABLET | Prescription | ORAL |