Leuprolide Acetate Patent Expiration

Leuprolide Acetate was first introduced by Abbvie Endocrine Inc in its drug Lupron on Apr 9, 1985. Other drugs containing Leuprolide Acetate are Eligard Kit, Viadur, Lupron Depot, Leuprolide Acetate For Depot Suspension, Fensolvi Kit, Lupron Depot-Ped Kit. 11 different companies have introduced drugs containing Leuprolide Acetate.


Leuprolide Acetate Patents

Given below is the list of patents protecting Leuprolide Acetate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Eligard Kit US11771841 Systems and methods for mixing syringe valve assemblies Dec 22, 2041 Tolmar
Eligard Kit US11931559 Systems and methods for mixing syringe valve assemblies Dec 22, 2041 Tolmar
Fensolvi Kit US11771841 Systems and methods for mixing syringe valve assemblies Dec 22, 2041 Tolmar
Fensolvi Kit US11931559 Systems and methods for mixing syringe valve assemblies Dec 22, 2041 Tolmar
Lupron Depot US8921326 Sustained-release composition and method for producing the same Feb 05, 2031 Abbvie Endocrine Inc
Lupron Depot-ped Kit US8921326 Sustained-release composition and method for producing the same Feb 05, 2031 Abbvie Endocrine Inc
Lupron Depot-ped Kit US9617303 Sustained-release composition and method for producing the same Mar 22, 2028 Abbvie Endocrine Inc
Eligard Kit US8470359 Sustained release polymer Oct 15, 2023

(Expired)

Tolmar
Fensolvi Kit US8470359 Sustained release polymer Oct 15, 2023

(Expired)

Tolmar
Lupron Depot US8815801 Controlled release composition and method of producing the same Jun 28, 2022

(Expired)

Abbvie Endocrine Inc
Leuprolide Acetate For Depot Suspension US9789064 Method for delivering a peptide to a subject at a modulated rate via microcapsules of lactic-co-glycolic copolymer containing said peptide Dec 15, 2020

(Expired)

Invagen Pharms
Eligard Kit US8840916 Sustained release polymer Nov 13, 2020

(Expired)

Tolmar
Eligard Kit US9539333 Sustained release polymer Nov 13, 2020

(Expired)

Tolmar
Eligard Kit US9914802 Sustained release polymer Nov 13, 2020

(Expired)

Tolmar
Fensolvi Kit US9539333 Sustained release polymer Nov 13, 2020

(Expired)

Tolmar
Fensolvi Kit US9914802 Sustained release polymer Nov 13, 2020

(Expired)

Tolmar
Eligard Kit US6626870 Stoppering method to maintain sterility Mar 27, 2020

(Expired)

Tolmar
Viadur US6375978 Rate controlling membranes for controlled drug delivery devices Dec 17, 2018

(Expired)

Ortho Mcneil Janssen
Eligard Kit US6565874 Polymeric delivery formulations of leuprolide with improved efficacy Oct 28, 2018

(Expired)

Tolmar
Eligard Kit US6773714 Polymeric delivery formulations of leuprolide with improved efficacy Oct 28, 2018

(Expired)

Tolmar
Eligard Kit US8486455 Polymeric delivery formulations of leuprolide with improved efficacy Oct 28, 2018

(Expired)

Tolmar
Eligard Kit US9254307 Polymeric delivery formulations of leuprolide with improved efficacy Oct 28, 2018

(Expired)

Tolmar
Eligard Kit US9283282 Sustained release polymer Oct 28, 2018

(Expired)

Tolmar
Viadur US6113938 Beneficial agent delivery system with membrane plug and method for controlling delivery of beneficial agents Jul 24, 2018

(Expired)

Ortho Mcneil Janssen
Viadur US5932547 Non-aqueous polar aprotic peptide formulations Jun 13, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US6124261 Non-aqueous polar aprotic peptide formulations Jun 13, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US6235712 Non-aqueous polar aprotic peptide formulations Jun 13, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US5728396 Sustained delivery of leuprolide using an implantable system Jan 30, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US5985305 Sustained delivery of an active agent using an implantable system Jan 30, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US6132420 Osmotic delivery system and method for enhancing start-up and performance of osmotic delivery systems Jan 30, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US6156331 Sustained delivery of an active agent using an implantable system Jan 30, 2017

(Expired)

Ortho Mcneil Janssen
Viadur US6395292 Sustained delivery of an active agent using an implantable system Jan 30, 2017

(Expired)

Ortho Mcneil Janssen
Lupron Depot US6036976 Sustained release microspheres and preparation thereof Dec 13, 2016

(Expired)

Abbvie Endocrine Inc
Lupron Depot US7429559 Controlled release composition and method of producing the same Dec 13, 2016

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US6036976 Sustained release microspheres and preparation thereof Dec 13, 2016

(Expired)

Abbvie Endocrine Inc
Lupron Depot US5631020 Method for producing microcapsule May 20, 2014

(Expired)

Abbvie Endocrine Inc
Lupron Depot US5631021 Method for producing microcapsule May 20, 2014

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US5631020 Method for producing microcapsule May 20, 2014

(Expired)

Abbvie Endocrine Inc
Eligard Kit US5599552 Biodegradable polymer composition Feb 04, 2014

(Expired)

Tolmar
Lupron Depot-ped Kit US6036976 Sustained release microspheres and preparation thereof Dec 13, 2013

(Expired)

Abbvie Endocrine Inc
Eligard Kit US6395293 Biodegradable implant precursor Sep 28, 2013

(Expired)

Tolmar
Lupron Depot US5575987 Method of producing sustained-release microcapsules Sep 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot US5716640 Method of producing sustained-release microcapsules Sep 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US5575987 Method of producing sustained-release microcapsules Sep 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US5716640 Method of producing sustained-release microcapsules Sep 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot US5480656 Prolonged release microcapsules Jan 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot US5643607 Prolonged release microcapsules Jan 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US5480656 Prolonged release microcapsules Jan 02, 2013

(Expired)

Abbvie Endocrine Inc
Lupron Depot-ped Kit US5643607 Prolonged release microcapsules Jan 02, 2013

(Expired)

Abbvie Endocrine Inc



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 Leuprolide Acetate's patents.

Given below is the list recent legal activities going on the following patents of Leuprolide Acetate.

Activity Date Patent Number
Patent litigations
Correspondence Address Change 23 Jun, 2016 US6395292
Change in Power of Attorney (May Include Associate POA) 24 Mar, 2015 US6395292
Correspondence Address Change 23 Mar, 2015 US6395292
Correspondence Address Change 26 Feb, 2008 US6395292
Change in Power of Attorney (May Include Associate POA) 31 Jan, 2008 US6395292
Correspondence Address Change 31 Jan, 2008 US6395292
Patent Issue Date Used in PTA Calculation 28 May, 2002 US6395292
Recordation of Patent Grant Mailed 28 May, 2002 US6395292
Issue Notification Mailed 10 May, 2002 US6395292
Receipt into Pubs 02 May, 2002 US6395292


Leuprolide Acetate's Family Patents

Family Patents

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Leuprolide Acetate Generics

Several generic applications have been filed for Leuprolide Acetate. The first generic version for Leuprolide Acetate was by Sandoz Inc and was approved on Aug 4, 1998. And the latest generic version is by Amneal Eu Ltd and was approved on Oct 28, 2022.

Given below is the list of companies who have filed for Leuprolide Acetate generic.


1. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Prescription SUBCUTANEOUS AP Oct 28, 2022


2. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Prescription SUBCUTANEOUS AP Jun 6, 2022


3. GENZYME

Genzyme Corporation has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Genzyme.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Discontinued SUBCUTANEOUS N/A Nov 29, 2001


4. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Prescription SUBCUTANEOUS AP Oct 25, 2000


5. RK PHARMA

Rk Pharma Inc has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Rk Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Prescription SUBCUTANEOUS AP Aug 13, 2021


6. SANDOZ

Sandoz Inc has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML)

(reference standard)

solution Prescription SUBCUTANEOUS AP Aug 4, 1998


7. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG/2.8ML (1MG/0.2ML) solution Prescription SUBCUTANEOUS AP Mar 9, 2009