Leuprolide Acetate Patent Expiration
Leuprolide Acetate was first introduced by Abbvie Endocrine Inc
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 | US9617303 | Sustained-release composition and method for producing the same | Mar 22, 2028 | 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.
Latest 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 |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 23 Jun, 2016 | US6395292 |
| Change in Power of Attorney (May Include Associate POA) Critical | 24 Mar, 2015 | US6395292 |
| Correspondence Address Change Critical | 23 Mar, 2015 | US6395292 |
| Correspondence Address Change Critical | 26 Feb, 2008 | US6395292 |
| Change in Power of Attorney (May Include Associate POA) Critical | 31 Jan, 2008 | US6395292 |
| Correspondence Address Change Critical | 31 Jan, 2008 | US6395292 |
| Patent Issue Date Used in PTA Calculation Critical | 28 May, 2002 | US6395292 |
| Recordation of Patent Grant Mailed Critical | 28 May, 2002 | US6395292 |
| Issue Notification Mailed Critical | 10 May, 2002 | US6395292 |
| Receipt into Pubs | 02 May, 2002 | US6395292 |
Leuprolide Acetate's Family Patents
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Leuprolide Acetate Generic API Manufacturers
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 Ubi Pharma Inc and was approved on Oct 17, 2024.
Given below is the list of companies who have filed for Leuprolide Acetate generic, along with the locations of their manufacturing plants worldwide.
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 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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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 |
Manufacturing Plant Locations New
Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
| |||||||
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 |
Manufacturing Plant Locations New
Genzyme's manufacturing plants are situated in 5 countries - United States, Belgium, Ireland, United Kingdom, France. Given below are the details of these plant locations as well as the firm names of Genzyme as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Belgium |
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| Ireland |
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| United Kingdom |
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| France |
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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 |
Manufacturing Plant Locations New
Rk Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Rk Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
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 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
| |||||
| United States |
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| Spain |
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| India |
| |||||
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 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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8. UBI
Ubi Pharma Inc has filed for 1 generic for Leuprolide Acetate. Given below are the details of the strengths of this generic introduced by Ubi.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 14MG/2.8ML (1MG/0.2ML) | solution | Prescription | SUBCUTANEOUS | AP | Oct 17, 2024 |