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 ninety-six 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:	96
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:	4,145
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
Brooks Rehabilitation	Phase 2
University of Florida	Phase 2

See all TESTOSTERONE ENANTHATE clinical trials

Pharmacology for TESTOSTERONE ENANTHATE

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE ENANTHATE

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma Farmaceutica	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	091120-001	Sep 18, 2012	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018	⤷ Sign Up	⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018	⤷ Sign Up	⤷ Sign Up
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	3659647	DISPOSITIF D'INJECTION À JET ASSISTÉ PAR UNE AIGUILLE AVEC RÉDUCTION DE LA FORCE DE DÉCLENCHEMENT (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE)	⤷ Sign Up
South Korea	20070117543	PREFILLED NEEDLE ASSISTED JET INJECTOR	⤷ Sign Up
Japan	2017523858	注射装置で使用するためのシリンジ緩衝器	⤷ Sign Up
Spain	2886553		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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