Nuvaring is a drug owned by Organon Usa Llc A Sub Of Organon And Co. 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 Apr 08, 2018. Details of Nuvaring'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). | |||
| US5989581 | Drug delivery system for two or more active substances |
Apr, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Nuvaring 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 Nuvaring's family patents as well as insights into ongoing legal events on those patents.
Nuvaring's Family Patents
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Generic Launch
Generic Release Date:
Nuvaring's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 08, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuvaring Generic API suppliers:
Ethinyl Estradiol; Etonogestrel is the generic name for the brand Nuvaring. 4 different companies have already filed for the generic of Nuvaring, with Dr Reddys Labs Sa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nuvaring's generic
How can I launch a generic of Nuvaring before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nuvaring's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nuvaring'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 Nuvaring -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.015 mg/24 hour 0.12 mg/24 hour | 17 Jun, 2013 | 1 | 08 Apr, 2018 | Extinguished |
About Nuvaring
Nuvaring is a drug owned by Organon Usa Llc A Sub Of Organon And Co. Nuvaring uses Ethinyl Estradiol; Etonogestrel as an active ingredient. Nuvaring was launched by Organon Usa Organon in 2001.
Approval Date:
Nuvaring was approved by FDA for market use on 03 October, 2001.
Active Ingredient:
Nuvaring uses Ethinyl Estradiol; Etonogestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Etonogestrel ingredient
Dosage:
Nuvaring is available in ring form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.015MG/24HR;0.12MG/24HR | RING | Prescription | VAGINAL |