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Last Updated: March 28, 2024

TESTOSTERONE ENANTHATE - Generic Drug Details


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What are the generic sources for testosterone enanthate and what is the scope of freedom to operate?

Testosterone enanthate is the generic ingredient in three branded drugs marketed by Endo Pharms, Hikma Farmaceutica, Nexus, Rising, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in eight NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Testosterone enanthate has eighty-nine patent family members in fourteen countries.

There are eight drug master file entries for testosterone enanthate. Two suppliers are listed for this compound.

Drug Prices for TESTOSTERONE ENANTHATE

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Recent Clinical Trials for TESTOSTERONE ENANTHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The University of Texas Medical Branch, GalvestonPhase 2/Phase 3
North Florida/South Georgia Veterans Health SystemPhase 2
North Florida Foundation for Research and EducationPhase 2

See all TESTOSTERONE ENANTHATE clinical trials

Pharmacology for TESTOSTERONE ENANTHATE
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for TESTOSTERONE ENANTHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TESTOSTERONE ENANTHATE

International Patents for TESTOSTERONE ENANTHATE

Country Patent Number Title Estimated Expiration
Japan 2016507305 トリガ力を低減した針支援式ジェット注射装置 ⤷  Try a Trial
Brazil PI0614025 injetores de jato ⤷  Try a Trial
Japan 5732039 ⤷  Try a Trial
Japan 5968976 ⤷  Try a Trial
European Patent Office 4186545 ADMINISTRATION PAR INJECTION PAR JET ASSISTÉE PAR AIGUILLE DE COMPOSITIONS DE TESTOSTÉRONE (NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS) ⤷  Try a Trial
South Korea 101597672 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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