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Last Updated: August 9, 2020

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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, Mylan Institutional, Nexus Pharms, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Testosterone enanthate has forty-two patent family members in thirteen countries.

There are sixty-nine 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
University of FloridaPhase 2
Brooks RehabilitationPhase 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 209863-003 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Endo Pharms DELATESTRYL testosterone enanthate INJECTABLE;INJECTION 009165-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan Institutional TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 040647-001 Oct 5, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018   Start Trial   Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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