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XYOSTED (AUTOINJECTOR) Drug Profile
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Which patents cover Xyosted (autoinjector), and when can generic versions of Xyosted (autoinjector) launch?
Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. There are nine patents protecting this drug.
This drug has fifty patent family members in fifteen countries.
The generic ingredient in XYOSTED (AUTOINJECTOR) is testosterone enanthate. There are sixty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the testosterone enanthate profile page.
US ANDA Litigation and Generic Entry Outlook for Xyosted (autoinjector)
A generic version of XYOSTED (AUTOINJECTOR) was approved as testosterone enanthate by WATSON PHARMS INC on January 24th, 2020.
Summary for XYOSTED (AUTOINJECTOR)
| International Patents: | 50 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XYOSTED (AUTOINJECTOR) |
| DailyMed Link: | XYOSTED (AUTOINJECTOR) at DailyMed |
-patent-expirations.png "XYOSTED (AUTOINJECTOR) drug patent expirations")
Recent Litigation for XYOSTED (AUTOINJECTOR)
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Antares Pharma Inc. v. Medac Pharma Inc. | 2014-07-21 |
Pharmacology for XYOSTED (AUTOINJECTOR)
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
US Patents and Regulatory Information for XYOSTED (AUTOINJECTOR)
| 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 | 209863-003 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-003 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 XYOSTED (AUTOINJECTOR)
| 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 | 209863-001 | 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 | 209863-001 | Sep 28, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XYOSTED (AUTOINJECTOR)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013169800 | Start Trial |
| Japan | 2015516845 | Start Trial |
| Hungary | E042286 | Start Trial |
| Portugal | 1850892 | Start Trial |
| European Patent Office | 1104317 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
