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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9271990 | Fulvestrant formulations |
May, 2034
(9 years from now) | Active |
| US9833459 | Fulvestrant formulations |
Feb, 2034
(9 years from now) | Active |
| US10188663 | Fulvestrant formulations |
Feb, 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 29 Jan, 2019 | US10188663 |
| Recordation of Patent Grant Mailed Critical | 29 Jan, 2019 | US10188663 |
| Email Notification Critical | 10 Jan, 2019 | US10188663 |
| Issue Notification Mailed Critical | 09 Jan, 2019 | US10188663 |
| Application Is Considered Ready for Issue Critical | 20 Dec, 2018 | US10188663 |
| Dispatch to FDC | 20 Dec, 2018 | US10188663 |
| Issue Fee Payment Verified Critical | 17 Dec, 2018 | US10188663 |
| Issue Fee Payment Received Critical | 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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
Alternative Brands for Fulvestrant
Fulvestrant which is used for treating hormone receptor-positive advanced breast cancer in postmenopausal women., has several other brand drugs using the same active ingredient (Fulvestrant). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Astrazeneca |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fulvestrant, Fulvestrant's active ingredient. Check the complete list of approved generic manufacturers for Fulvestrant
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.
Approval 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 |