Fulvestrant is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 17, 2034. Details of Fulvestrant'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9833459 | Fulvestrant formulations |
Feb, 2034
(9 years from now) | Active |
| US10188663 | Fulvestrant formulations |
Feb, 2034
(9 years from now) | Active |
| US9271990 | Fulvestrant formulations |
May, 2034
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Fulvestrant's patents.
Latest Legal Activities on Fulvestrant's Patents
Given below is the list of recent legal activities going on the following patents of Fulvestrant.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Jul, 2022 | US10188663 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jun, 2021 | US9833459 |
| Patent Issue Date Used in PTA Calculation | 29 Jan, 2019 | US10188663 |
| Recordation of Patent Grant Mailed | 29 Jan, 2019 | US10188663 |
| Email Notification | 10 Jan, 2019 | US10188663 |
| Issue Notification Mailed | 09 Jan, 2019 | US10188663 |
| Application Is Considered Ready for Issue | 20 Dec, 2018 | US10188663 |
| Dispatch to FDC | 20 Dec, 2018 | US10188663 |
| Issue Fee Payment Verified | 17 Dec, 2018 | US10188663 |
| Issue Fee Payment Received | 17 Dec, 2018 | US10188663 |
US patents provide insights into the exclusivity only within the United States, but Fulvestrant 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 Fulvestrant's family patents as well as insights into ongoing legal events on those patents.
Fulvestrant's family patents
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Generic Launch
Generic Release Date:
Fulvestrant's generic launch date based on the expiry of its last outstanding patent is estimated to be May 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fulvestrant Generics:
Fulvestrant is the generic name for the brand Fulvestrant. 14 different companies have already filed for the generic of Fulvestrant, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fulvestrant's generic
About Fulvestrant
Fulvestrant is a drug owned by Fresenius Kabi Usa Llc. It is used for treating hormone receptor-positive advanced breast cancer in postmenopausal women. Fulvestrant uses Fulvestrant as an active ingredient. Fulvestrant was launched by Fresenius Kabi Usa in 2019.
Market Authorisation Date:
Fulvestrant was approved by FDA for market use on 20 May, 2019.
Active Ingredient:
Fulvestrant uses Fulvestrant as the active ingredient. Check out other Drugs and Companies using Fulvestrant ingredient
Treatment:
Fulvestrant is used for treating hormone receptor-positive advanced breast cancer in postmenopausal women.
Dosage:
Fulvestrant is available in solution form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/5ML (50MG/ML) | SOLUTION | Prescription | INTRAMUSCULAR |