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Last Updated: April 19, 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, Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in nine 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. Three suppliers are listed for this compound.

Summary for TESTOSTERONE ENANTHATE

International Patents:	89
US Patents:	23
Tradenames:	3
Applicants:	8
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	39
Patent Applications:	4,406
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for TESTOSTERONE ENANTHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TESTOSTERONE ENANTHATE
What excipients (inactive ingredients) are in TESTOSTERONE ENANTHATE?	TESTOSTERONE ENANTHATE excipients list
DailyMed Link:	TESTOSTERONE ENANTHATE at DailyMed

See drug prices for TESTOSTERONE ENANTHATE

Recent Clinical Trials for TESTOSTERONE ENANTHATE

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Phase 2/Phase 3
North Florida Foundation for Research and Education	Phase 2
Brooks Rehabilitation	Phase 2

See all TESTOSTERONE ENANTHATE clinical trials

Pharmacology for TESTOSTERONE ENANTHATE

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for TESTOSTERONE ENANTHATE

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Glossary

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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	209863-003	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	209863-003	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

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

International Patents for TESTOSTERONE ENANTHATE

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Country	Patent Number	Title	Estimated Expiration
Canada	2868500	ADMINISTRATION PAR INJECTION PAR JET ASSISTEE PAR UNE AIGUILLE DE COMPOSITIONS DE TESTOSTERONE (NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS)	⤷ Try a Trial
European Patent Office	3675868	FORMULATIONS DE TRIGLYCÉRIDES D'ESTER DE TESTOSTÉRONE (TESTOSTERONE ESTER TRIGLYCERIDE FORMULATIONS)	⤷ Try a Trial
Canada	3072198	FORMULATIONS DE TRIGLYCERIDES D'ESTER DE TESTOSTERONE (TESTOSTERONE ESTER TRIGLYCERIDE FORMULATIONS)	⤷ Try a Trial
Japan	2020532503	テストステロンエステルトリグリセリド製剤	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.