Details for New Drug Application (NDA): 209863
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.
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: | 10,238,662 | Patent Expiration: | Feb 19, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY | ||||||||
| Patent: | 10,279,131 | Patent Expiration: | Jul 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,357,609 | Patent Expiration: | Aug 21, 2031 | Product Flag? | Y | Substance 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 | RE44846 | ⤷ Start Trial |
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | 10,478,560 | ⤷ Start Trial |
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | 9,629,959 | ⤷ Start Trial |
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RE44847 | ⤷ Start Trial |
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | RE44846 | ⤷ Start Trial |
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-001 | Sep 28, 2018 | 8,562,564 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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