Ortho Tri-cyclen Lo 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 Dec 09, 2019. Details of Ortho Tri-cyclen Lo'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). | |||
|
US6214815 (Pediatric) | Triphasic oral contraceptive |
Dec, 2019
(4 years ago) |
Expired
|
| US6214815 | Triphasic oral contraceptive |
Jun, 2019
(5 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ortho Tri-cyclen Lo 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 Tri-cyclen Lo's family patents as well as insights into ongoing legal events on those patents.
Ortho Tri-cyclen Lo's Family Patents
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Generic Launch
Generic Release Date:
Ortho Tri-cyclen Lo's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 09, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ortho Tri-cyclen Lo Generic API suppliers:
Ethinyl Estradiol; Norgestimate is the generic name for the brand Ortho Tri-cyclen Lo. 16 different companies have already filed for the generic of Ortho Tri-cyclen Lo, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ortho Tri-cyclen Lo's generic
How can I launch a generic of Ortho Tri-cyclen Lo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ortho Tri-cyclen Lo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ortho Tri-cyclen Lo'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 Tri-cyclen Lo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg |
About Ortho Tri-cyclen Lo
Ortho Tri-Cyclen Lo is a drug owned by Janssen Pharmaceuticals Inc. It is used for preventing pregnancy. Ortho Tri-Cyclen Lo uses Ethinyl Estradiol; Norgestimate as an active ingredient. Ortho Tri-Cyclen Lo was launched by Janssen Pharms in 2002.
Approval Date:
Ortho Tri-cyclen Lo was approved by FDA for market use on 22 August, 2002.
Active Ingredient:
Ortho Tri-cyclen Lo uses Ethinyl Estradiol; Norgestimate as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Norgestimate ingredient
Treatment:
Ortho Tri-cyclen Lo is used for preventing pregnancy.
Dosage:
Ortho Tri-cyclen Lo is available in tablet form for oral-28 use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL-28 |