Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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 nine 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:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 209863
Mechanism of ActionAndrogen 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:RXDosage:SOLUTION;SUBCUTANEOUSStrength50MG/0.5ML (50MG/0.5ML)
Approval Date:Sep 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 28, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jan 24, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 209863

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   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 209863-003 Sep 28, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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