Faslodex is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 8 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 Jul 09, 2021. Details of Faslodex'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). | |||
|
US6774122 (Pediatric) | Formulation |
Jul, 2021
(5 years ago) |
Expired
|
|
US8466139 (Pediatric) | Formulation |
Jul, 2021
(5 years ago) |
Expired
|
|
US8329680 (Pediatric) | Formulation |
Jul, 2021
(5 years ago) |
Expired
|
|
US7456160 (Pediatric) | Formulation |
Jul, 2021
(5 years ago) |
Expired
|
| US8466139 | Formulation |
Jan, 2021
(5 years ago) |
Expired
|
| US8329680 | Formulation |
Jan, 2021
(5 years ago) |
Expired
|
| US6774122 | Formulation |
Jan, 2021
(5 years ago) |
Expired
|
| US7456160 | Formulation |
Jan, 2021
(5 years ago) |
Expired
|
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 Faslodex's patents.
Latest Legal Activities on Faslodex's Patents
Given below is the list of recent legal activities going on the following patents of Faslodex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 21 Jul, 2025 | US8466139 (Litigated) |
| Maintenance Fee Reminder Mailed | 03 Feb, 2025 | US8466139 (Litigated) |
| Expire Patent | 13 Jan, 2025 | US8329680 (Litigated) |
| Maintenance Fee Reminder Mailed | 29 Jul, 2024 | US8329680 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8466139 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 May, 2020 | US8329680 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 May, 2020 | US7456160 (Litigated) |
| Request for Trial Denied
Critical | 11 Dec, 2017 | US8329680 (Litigated) |
| Request for Trial Denied
Critical | 11 Dec, 2017 | US6774122 |
| Request for Trial Denied
Critical | 11 Dec, 2017 | US8466139 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Faslodex and ongoing
litigations to
help you estimate the early arrival of Faslodex generic.
Faslodex's Litigations
Faslodex been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 29, 2016, against patent number US8329680. The petitioner Mylan Pharmaceuticals Inc. et al., challenged the validity of this patent, with AstraZeneca AB et al. as the respondent. Click below to track the latest information on how companies are challenging Faslodex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6774122 | August, 2017 |
Institution Denied
(11 Dec, 2017) | AstraZeneca AB | Fresenius Kabi USA,LLC |
| US8329680 | August, 2017 |
Institution Denied
(11 Dec, 2017) | AstraZeneca AB | Fresenius Kabi USA, LLC |
| US8466139 | August, 2017 |
Institution Denied
(11 Dec, 2017) | AstraZeneca AB | FRESENIUS KABI USA, LLC |
| US6774122 | February, 2017 |
Institution Denied
(30 Aug, 2017) | AstraZeneca AB | InnoPharma Licensing LLC et al. |
| US8329680 | February, 2017 |
Institution Denied
(30 Aug, 2017) | AstraZeneca AB | InnoPharma Licensing LLC et al. |
| US8466139 | February, 2017 |
Institution Denied
(30 Aug, 2017) | AstraZeneca AB | InnoPharma Licensing LLC et al. |
| US6774122 | June, 2016 |
Terminated-Settled
(10 Jan, 2017) | AstraZeneca AB | Mylan Pharmaceuticals Inc. |
| US7456160 | June, 2016 |
Terminated-Settled
(10 Jan, 2017) | AstraZeneca AB | Mylan Pharmaceuticals Inc. |
| US8466139 | June, 2016 |
Terminated-Settled
(10 Jan, 2017) | AstraZeneca AB | Mylan Pharmaceuticals Inc. |
| US8329680 | June, 2016 |
Institution Denied
(14 Dec, 2016) | AstraZeneca AB et al. | Mylan Pharmaceuticals Inc. et al. |
FDA has granted some exclusivities to Faslodex. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Faslodex,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Faslodex.
Exclusivity Information
Faslodex holds 6 exclusivities. All of its exclusivities have expired in 2020. Details of Faslodex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-126) | Sep 09, 2013 |
| Pediatric Exclusivity(PED) | Mar 09, 2014 |
| M(M-103) | May 17, 2014 |
| M(M-123) | Nov 09, 2015 |
| New Indication(I-725) | Feb 19, 2019 |
| New Indication(I-749) | Aug 25, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Faslodex 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 Faslodex's family patents as well as insights into
ongoing legal events
on those patents.
Faslodex's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Faslodex:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Faslodex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 09, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Faslodex Generic API suppliers:
Fulvestrant is the generic name for the brand Faslodex. 14 different companies have already filed for the generic of Faslodex, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Faslodex's generic
How can I launch a generic of Faslodex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Faslodex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Faslodex'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 Faslodex -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 01 Oct, 2009 | 09 Jan, 2021 | Extinguished | Less |
Alternative Brands for Faslodex
Faslodex which is used for treating hormone receptor positive metastatic 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 | |
|---|---|---|
| Fresenius Kabi Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fulvestrant, Faslodex's active ingredient. Check the complete list of approved generic manufacturers for Faslodex
About Faslodex
Faslodex is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating hormone receptor positive metastatic breast cancer in postmenopausal women. Faslodex uses Fulvestrant as an active ingredient. Faslodex was launched by Astrazeneca in 2002.
Approval Date:
Faslodex was approved by FDA for market use on 25 April, 2002.
Active Ingredient:
Faslodex uses Fulvestrant as the active ingredient. Check out other Drugs and Companies using Fulvestrant ingredient
Treatment:
Faslodex is used for treating hormone receptor positive metastatic breast cancer in postmenopausal women.
Dosage:
Faslodex 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 |