Details for New Drug Application (NDA): 209863

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NDA 209863 describes XYOSTED (AUTOINJECTOR), which is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are twenty-three patents protecting this drug. Additional details are available on the XYOSTED (AUTOINJECTOR) profile page.

The generic ingredient in XYOSTED (AUTOINJECTOR) is testosterone enanthate. There are sixty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the testosterone enanthate profile page.

Summary for 209863

Tradename:	XYOSTED (AUTOINJECTOR)
Applicant:	Antares Pharma Inc
Ingredient:	testosterone enanthate
Patents:	23

Pharmacology for NDA: 209863

Mechanism of Action	Androgen Receptor Agonists

Suppliers and Packaging for NDA: 209863

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863	NDA	Antares Pharma, Inc.	54436-200	54436-200-01	1 SYRINGE in 1 CARTON (54436-200-01) / .5 mL in 1 SYRINGE (54436-200-03)
XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863	NDA	Antares Pharma, Inc.	54436-200	54436-200-04	4 SYRINGE in 1 CARTON (54436-200-04) / .5 mL in 1 SYRINGE (54436-200-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	50MG/0.5ML (50MG/0.5ML)
Approval Date:	Sep 28, 2018	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 19, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
Patent:	⤷ Sign Up	Patent Expiration:	Jul 31, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 21, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209863

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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	209863-002	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	209863-001	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

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