Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209863

✉ Email this page to a colleague

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 is one drug master file entry 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:	⤷ Start Trial	Patent Expiration:	Feb 19, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
Patent:	⤷ Start Trial	Patent Expiration:	Jul 31, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Aug 21, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209863

Subscribe to access the full database, or Start Trial
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	209863-002	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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.