Lupron Depot-ped Kit is a drug owned by Abbvie Endocrine Inc. It is protected by 8 US drug patents filed from 2013 to 2023. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 05, 2031. Details of Lupron Depot-ped Kit'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
(6 years from now) | Active |
| US9617303 | Sustained-release composition and method for producing the same |
Mar, 2028
(3 years from now) | Active |
| US6036976 | Sustained release microspheres and preparation thereof |
Dec, 2013
(10 years ago) |
Expired
|
| US5631020 | Method for producing microcapsule |
May, 2014
(10 years ago) |
Expired
|
| US5716640 | Method of producing sustained-release microcapsules |
Sep, 2013
(11 years ago) |
Expired
|
| US5575987 | Method of producing sustained-release microcapsules |
Sep, 2013
(11 years ago) |
Expired
|
| US5643607 | Prolonged release microcapsules |
Jan, 2013
(11 years ago) |
Expired
|
| US5480656 | Prolonged release microcapsules |
Jan, 2013
(11 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-ped Kit's patents.
Latest Legal Activities on Lupron Depot-ped Kit's Patents
Given below is the list of recent legal activities going on the following patents of Lupron Depot-ped Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2022 | US8921326 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Sep, 2020 | US9617303 |
| Post Issue Communication - Certificate of Correction | 10 Sep, 2018 | US9617303 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jun, 2018 | US8921326 |
| Mail O.P. Petition Decision | 13 Jun, 2017 | US9617303 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 12 Jun, 2017 | US9617303 |
| O.P. Petition Decision | 09 Jun, 2017 | US9617303 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 09 Jun, 2017 | US9617303 |
| Adjustment of PTA Calculation by PTO | 09 Jun, 2017 | US9617303 |
| Petition Entered | 17 Apr, 2017 | US9617303 |
FDA has granted several exclusivities to Lupron Depot-ped Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lupron Depot-ped Kit, 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-ped Kit.
Exclusivity Information
Lupron Depot-ped Kit holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Lupron Depot-ped Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 15, 2014 |
| M(M-107) | Oct 08, 2014 |
| New Strength(NS) | Apr 14, 2026 |
Several oppositions have been filed on Lupron Depot-ped Kit'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-ped Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lupron Depot-ped Kit patents.
Lupron Depot-ped Kit's Oppositions Filed in EPO
Lupron Depot-ped Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 16, 2020, by Instone Terry/ Read Howard Graham/Appleyard Lees Ip Llp. This opposition was filed on patent number EP07859925A. 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 |
US patents provide insights into the exclusivity only within the United States, but Lupron Depot-ped Kit 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-ped Kit's family patents as well as insights into ongoing legal events on those patents.
Lupron Depot-ped Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lupron Depot-ped Kit'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-ped Kit Generic API suppliers:
Leuprolide Acetate is the generic name for the brand Lupron Depot-ped Kit. 8 different companies have already filed for the generic of Lupron Depot-ped Kit, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lupron Depot-ped Kit's generic
Alternative Brands for Lupron Depot-ped Kit
Lupron Depot-ped Kit which is used for treating central precocious puberty in pediatric patients., has several other brand drugs 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 | ||
|---|---|---|---|
| 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-ped Kit's active ingredient. Check the complete list of approved generic manufacturers for Lupron Depot-ped Kit
About Lupron Depot-ped Kit
Lupron Depot-Ped Kit is a drug owned by Abbvie Endocrine Inc. It is used for treating central precocious puberty in pediatric patients. Lupron Depot-Ped Kit uses Leuprolide Acetate as an active ingredient. Lupron Depot-Ped Kit was launched by Abbvie Endocrine Inc in 1993.
Approval Date:
Lupron Depot-ped Kit was approved by FDA for market use on 16 April, 1993.
Active Ingredient:
Lupron Depot-ped Kit uses Leuprolide Acetate as the active ingredient. Check out other Drugs and Companies using Leuprolide Acetate ingredient
Treatment:
Lupron Depot-ped Kit is used for treating central precocious puberty in pediatric patients.
Dosage:
Lupron Depot-ped Kit is available in powder form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG | POWDER | Prescription | INTRAMUSCULAR |
| 11.25MG | POWDER | Prescription | INTRAMUSCULAR |
| 7.5MG | POWDER | Prescription | INTRAMUSCULAR |
| 30MG | POWDER | Prescription | INTRAMUSCULAR |
| 15MG | POWDER | Prescription | INTRAMUSCULAR |
| 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | Discontinued | INTRAMUSCULAR |
| 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | Discontinued | INTRAMUSCULAR |