Ortho Evra is a drug owned by Janssen Pharmaceuticals 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 Nov 20, 2015. Details of Ortho Evra'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). | |||
| US5876746 | Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen |
Nov, 2015
(9 years ago) |
Expired
|
| US5972377 | Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen |
Jun, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ortho Evra 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 Ortho Evra's family patents as well as insights into ongoing legal events on those patents.
Ortho Evra's Family Patents
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Generic Launch
Generic Release Date:
Ortho Evra's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 20, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ortho Evra Generic API suppliers:
Ethinyl Estradiol; Norelgestromin is the generic name for the brand Ortho Evra. 4 different companies have already filed for the generic of Ortho Evra, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ortho Evra's generic
How can I launch a generic of Ortho Evra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ortho Evra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ortho Evra'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 Ortho Evra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.15 mg/0.02 mg per 24 hours | 22 Mar, 2007 | 1 | 20 Nov, 2015 | Extinguished |
About Ortho Evra
Ortho Evra is a drug owned by Janssen Pharmaceuticals Inc. It is used for preventing ovulation in women. Ortho Evra uses Ethinyl Estradiol; Norelgestromin as an active ingredient. Ortho Evra was launched by Janssen Pharms in 2001.
Approval Date:
Ortho Evra was approved by FDA for market use on 20 November, 2001.
Active Ingredient:
Ortho Evra uses Ethinyl Estradiol; Norelgestromin as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Norelgestromin ingredient
Treatment:
Ortho Evra is used for preventing ovulation in women.
Dosage:
Ortho Evra is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE | Discontinued | TRANSDERMAL |