Lupron Depot is a drug owned by Abbvie Endocrine Inc. It is protected by 11 US drug patents filed from 2013 to 2024. Out of these, 2 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 05, 2031. Details of Lupron Depot'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). | |||
| US8921326 | Sustained-release composition and method for producing the same |
Feb, 2031
(5 years from now) | Active |
| US9617303 | Sustained-release composition and method for producing the same |
Mar, 2028
(2 years from now) | Active |
| US8815801 | Controlled release composition and method of producing the same |
Jun, 2022
(2 years ago) |
Expired
|
| US7429559 | Controlled release composition and method of producing the same |
Dec, 2016
(8 years ago) |
Expired
|
| US6036976 | Sustained release microspheres and preparation thereof |
Dec, 2016
(8 years ago) |
Expired
|
| US5631020 | Method for producing microcapsule |
May, 2014
(10 years ago) |
Expired
|
| US5631021 | Method for producing microcapsule |
May, 2014
(10 years ago) |
Expired
|
| US5575987 | Method of producing sustained-release microcapsules |
Sep, 2013
(11 years ago) |
Expired
|
| US5716640 | Method of producing sustained-release microcapsules |
Sep, 2013
(11 years ago) |
Expired
|
| US5480656 | Prolonged release microcapsules |
Jan, 2013
(12 years ago) |
Expired
|
| US5643607 | Prolonged release microcapsules |
Jan, 2013
(12 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 Lupron Depot's patents.
Latest Legal Activities on Lupron Depot's Patents
Given below is the list of recent legal activities going on the following patents of Lupron Depot.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2022 | US8921326 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jan, 2022 | US8815801 |
| Expire Patent Critical | 02 Nov, 2020 | US7429559 |
| Maintenance Fee Reminder Mailed Critical | 18 May, 2020 | US7429559 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jun, 2018 | US8921326 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2018 | US8815801 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Dec, 2014 | US8921326 |
| Recordation of Patent Grant Mailed Critical | 30 Dec, 2014 | US8921326 |
| Email Notification Critical | 11 Dec, 2014 | US8921326 |
| Issue Notification Mailed Critical | 10 Dec, 2014 | US8921326 |
FDA has granted several exclusivities to Lupron Depot. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lupron Depot, 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 Lupron Depot.
Exclusivity Information
Lupron Depot holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Lupron Depot's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-132) | Jun 17, 2014 |
| New Strength(NS) | Jun 17, 2014 |
Several oppositions have been filed on Lupron Depot's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Lupron Depot's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lupron Depot patents.
Lupron Depot's Oppositions Filed in EPO
Lupron Depot has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 18, 2006, by Astellas B.V. Et Al.. This opposition was filed on patent number EP02738838A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07859925A | Dec, 2020 | Instone Terry/ Read Howard Graham/Appleyard Lees IP LLP | Granted and Under Opposition |
| EP02738838A | Feb, 2007 | QLT USA, Inc. | Patent maintained as amended |
| EP02738838A | May, 2006 | MediGene Aktiengesellschaft | Patent maintained as amended |
| EP02738838A | May, 2006 | Astellas B.V. et al. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Lupron Depot 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 Lupron Depot's family patents as well as insights into ongoing legal events on those patents.
Lupron Depot's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lupron Depot's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 05, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lupron Depot Generic API suppliers:
Leuprolide Acetate is the generic name for the brand Lupron Depot. 8 different companies have already filed for the generic of Lupron Depot, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lupron Depot's generic
How can I launch a generic of Lupron Depot before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lupron Depot's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lupron Depot'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 Lupron Depot -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 7.5 mg/vial |
Alternative Brands for Lupron Depot
Lupron Depot which is used for managing symptoms and improving quality of life in patients with advanced prostate cancer., has several other brand drugs in the same treatment category and using the same active ingredient (Leuprolide Acetate). 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 | Treatment Area | ||
|---|---|---|---|---|
| Tolmar |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Leuprolide Acetate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie Endocrine |
| |
| Abbvie Endocrine Inc |
| |
| Invagen Pharms |
| |
| Ortho Mcneil Janssen |
| |
| Tolmar |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Leuprolide Acetate, Lupron Depot's active ingredient. Check the complete list of approved generic manufacturers for Lupron Depot
About Lupron Depot
Lupron Depot is a drug owned by Abbvie Endocrine Inc. It is used for managing symptoms and improving quality of life in patients with advanced prostate cancer. Lupron Depot uses Leuprolide Acetate as an active ingredient. Lupron Depot was launched by Abbvie Endocrine Inc in 1995.
Approval Date:
Lupron Depot was approved by FDA for market use on 22 December, 1995.
Active Ingredient:
Lupron Depot uses Leuprolide Acetate as the active ingredient. Check out other Drugs and Companies using Leuprolide Acetate ingredient
Treatment:
Lupron Depot is used for managing symptoms and improving quality of life in patients with advanced prostate cancer.
Dosage:
Lupron Depot is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG | INJECTABLE | Prescription | INJECTION |
| 11.25MG | INJECTABLE | Prescription | INJECTION |
| 30MG | INJECTABLE | Prescription | INJECTION |
| 7.5MG | INJECTABLE | Prescription | INJECTION |
| 22.5MG | INJECTABLE | Prescription | INJECTION |
| 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |