Testosterone Enanthate Patent Expiration

Testosterone Enanthate is Used for testosterone replacement therapy in individuals with low testosterone levels. It was first introduced by Endo Pharmaceuticals Inc in its drug Delatestryl on Approved Prior to Jan 1, 1982. Another drug containing Testosterone Enanthate is Xyosted (Autoinjector). 8 different companies have introduced drugs containing Testosterone Enanthate.


Testosterone Enanthate Patents

Given below is the list of patents protecting Testosterone Enanthate, 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
Xyosted (autoinjector) US10238662 Needle assisted jet injection administration of testosterone compositions Feb 19, 2035 Antares Pharma Inc
Xyosted (autoinjector) US10279131 Injection device with cammed RAM assembly Jul 31, 2031 Antares Pharma Inc
Xyosted (autoinjector) US10357609 Needle assisted jet injection device having reduced trigger force Aug 21, 2031 Antares Pharma Inc
Xyosted (autoinjector) US10478560 Prefilled syringe injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US10646495 Testosterone ester triglyceride formulations Aug 30, 2038 Antares Pharma Inc
Xyosted (autoinjector) US10821072 Needle assisted jet injection administration of testosterone compositions Jun 04, 2033 Antares Pharma Inc
Xyosted (autoinjector) US10881798 Needle assisted injection device having reduced trigger force Feb 11, 2034 Antares Pharma Inc
Xyosted (autoinjector) US10905827 Injection device with cammed ram assembly Aug 21, 2031 Antares Pharma Inc
Xyosted (autoinjector) US10912782 Needle assisted injection administration of testosterone compositions Feb 19, 2035 Antares Pharma Inc
Xyosted (autoinjector) US11160751 Hematocrit modulation through needle assisted jet injection of testosterone Oct 07, 2034 Antares Pharma Inc
Xyosted (autoinjector) US11191908 Syringe shock absorber for use in an injection device Oct 18, 2035 Antares Pharma Inc
Xyosted (autoinjector) US11446440 Needle assisted injection device having reduced trigger force Aug 21, 2031 Antares Pharma Inc
Xyosted (autoinjector) US11446441 Prefilled syringe injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US11497753 Hazardous agent injection system Mar 19, 2030 Antares Pharma Inc
Xyosted (autoinjector) US11771646 Needle assisted jet injection administration of testosterone compositions Apr 10, 2034 Antares Pharma Inc
Xyosted (autoinjector) US11813435 Needle assisted injection device having reduced trigger force Feb 25, 2035 Antares Pharma Inc
Xyosted (autoinjector) US11844804 Administration of testosterone compositions Jun 04, 2033 Antares Pharma Inc
Xyosted (autoinjector) US8021335 Prefilled syringe jet injector Oct 04, 2026 Antares Pharma Inc
Xyosted (autoinjector) US8562564 Prefilled syringe jet injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US9180259 Prefilled syringe jet injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US9533102 Prefilled syringe jet injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US9629959 Prefilled syringe jet injector Jan 24, 2026 Antares Pharma Inc
Xyosted (autoinjector) US9744302 Needle assisted jet injection device having reduced trigger force Nov 19, 2035 Antares Pharma Inc
Xyosted (autoinjector) US9950125 Needle assisted jet injection administration of testosterone compositions Sep 04, 2036 Antares Pharma Inc
Xyosted (autoinjector) USRE44846 Needle assisted jet injector Aug 10, 2019

(Expired)

Antares Pharma Inc
Xyosted (autoinjector) USRE44847 Needle assisted jet injector Aug 10, 2019

(Expired)

Antares Pharma 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 Testosterone Enanthate's patents.

Given below is the list recent legal activities going on the following patents of Testosterone Enanthate.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 01 Jul, 2024 US10881798
Payment of Maintenance Fee, 4th Year, Large Entity 01 May, 2024 US10821072
Email Notification 20 Dec, 2023 US11844804
Recordation of Patent Grant Mailed 19 Dec, 2023 US11844804
Patent eGrant Notification 19 Dec, 2023 US11844804
Recordation of Patent eGrant 19 Dec, 2023 US11844804
Patent Issue Date Used in PTA Calculation 19 Dec, 2023 US11844804
Mail Patent eGrant Notification 19 Dec, 2023 US11844804
Email Notification 30 Nov, 2023 US11844804
Issue Notification Mailed 29 Nov, 2023 US11844804



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Testosterone Enanthate Generics

Several generic applications have been filed for Testosterone Enanthate. The first generic version for Testosterone Enanthate was by Watson Laboratories Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Feb 28, 2024.

Given below is the list of companies who have filed for Testosterone Enanthate generic.


1. RISING

Rising Pharma Holding Inc has filed for 1 generic for Testosterone Enanthate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML injectable Discontinued INJECTION N/A Oct 5, 2009


2. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Testosterone Enanthate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982
200MG/ML injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982


3. NEXUS

Nexus Pharmaceuticals Llc has filed for 1 generic for Testosterone Enanthate. Given below are the details of the strengths of this generic introduced by Nexus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML injectable Prescription INJECTION AO Jun 14, 2006


4. HIKMA FARMACEUTICA

Hikma Farmaceutica Portugal Sa has filed for 1 generic for Testosterone Enanthate. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML injectable Prescription INJECTION AO Sep 18, 2012


5. WATSON PHARMS INC

Watson Pharmaceuticals Inc has filed for 1 generic for Testosterone Enanthate. Given below are the details of the strengths of this generic introduced by Watson Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

(reference standard)

injectable Prescription INJECTION AO Approved Prior to Jan 1, 1982


6. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Testosterone Enanthate. 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
200MG/ML injectable Prescription INJECTION AO Feb 28, 2024