Ganirelix Acetate is a drug owned by Organon Usa Llc A Sub Of Organon And Co. 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 16, 2018. Details of Ganirelix Acetate'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). | |||
| US6653286 | Gonadotropin releasing hormone antagonist |
Jun, 2018
(6 years ago) |
Expired
|
| US5767082 | Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists |
Jun, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ganirelix Acetate 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 Ganirelix Acetate's family patents as well as insights into ongoing legal events on those patents.
Ganirelix Acetate's Family Patents
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Generic Launch
Generic Release Date:
Ganirelix Acetate's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 16, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ganirelix Acetate Generic API suppliers:
Ganirelix Acetate is the generic name for the brand Ganirelix Acetate. 5 different companies have already filed for the generic of Ganirelix Acetate, with Amphastar Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ganirelix Acetate's generic
How can I launch a generic of Ganirelix Acetate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ganirelix Acetate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ganirelix Acetate'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 Ganirelix Acetate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mcg/0.5 mL, 1 mL PFS | 30 Mar, 2012 | 1 | 30 Nov, 2018 | 16 Jun, 2015 | Extinguished |
About Ganirelix Acetate
Ganirelix Acetate is a drug owned by Organon Usa Llc A Sub Of Organon And Co. It is used for preventing premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH. Ganirelix Acetate uses Ganirelix Acetate as an active ingredient. Ganirelix Acetate was launched by Organon Usa Organon in 1999.
Approval Date:
Ganirelix Acetate was approved by FDA for market use on 29 July, 1999.
Active Ingredient:
Ganirelix Acetate uses Ganirelix Acetate as the active ingredient. Check out other Drugs and Companies using Ganirelix Acetate ingredient
Treatment:
Ganirelix Acetate is used for preventing premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH.
Dosage:
Ganirelix Acetate is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MCG/0.5ML | INJECTABLE | Prescription | INJECTION |