Xyosted (autoinjector) is a drug owned by Antares Pharma Inc. It is protected by 26 US drug patents filed from 2018 to 2024. Out of these, 24 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2038. Details of Xyosted (autoinjector)'s patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE44847 | Needle assisted jet injector |
Aug, 2019
(4 years ago) |
Expired
|
| USRE44846 | Needle assisted jet injector |
Aug, 2019
(4 years ago) |
Expired
|
| US10478560 | Prefilled syringe injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US9533102 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US8562564 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US9629959 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US11446441 | Prefilled syringe injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US9180259 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 5 months from now) | Active |
| US8021335 | Prefilled syringe jet injector |
Oct, 2026
(2 years from now) | Active |
| US11497753 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US10279131 | Injection device with cammed RAM assembly |
Jul, 2031
(7 years from now) | Active |
| US10905827 | Injection device with cammed ram assembly |
Aug, 2031
(7 years from now) | Active |
| US11446440 | Needle assisted injection device having reduced trigger force |
Aug, 2031
(7 years from now) | Active |
| US10357609 | Needle assisted jet injection device having reduced trigger force |
Aug, 2031
(7 years from now) | Active |
| US10821072 | Needle assisted jet injection administration of testosterone compositions |
Jun, 2033
(8 years from now) | Active |
| US11844804 | Administration of testosterone compositions |
Jun, 2033
(8 years from now) | Active |
| US10881798 | Needle assisted injection device having reduced trigger force |
Feb, 2034
(9 years from now) | Active |
| US11771646 | Needle assisted jet injection administration of testosterone compositions |
Apr, 2034
(9 years from now) | Active |
| US11160751 | Hematocrit modulation through needle assisted jet injection of testosterone |
Oct, 2034
(10 years from now) | Active |
| US10912782 | Needle assisted injection administration of testosterone compositions |
Feb, 2035
(10 years from now) | Active |
| US10238662 | Needle assisted jet injection administration of testosterone compositions |
Feb, 2035
(10 years from now) | Active |
| US11813435 | Needle assisted injection device having reduced trigger force |
Feb, 2035
(10 years from now) | Active |
| US11191908 | Syringe shock absorber for use in an injection device |
Oct, 2035
(11 years from now) | Active |
| US9744302 | Needle assisted jet injection device having reduced trigger force |
Nov, 2035
(11 years from now) | Active |
| US9950125 | Needle assisted jet injection administration of testosterone compositions |
Sep, 2036
(12 years from now) | Active |
| US10646495 | Testosterone ester triglyceride formulations |
Aug, 2038
(14 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xyosted (autoinjector)'s patents.
Latest Legal Activities on Xyosted (autoinjector)'s Patents
Given below is the list of recent legal activities going on the following patents of Xyosted (autoinjector).
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Jul, 2024 | US10881798 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 May, 2024 | US10821072 |
| Email Notification | 20 Dec, 2023 | US11844804 |
| Recordation of Patent Grant Mailed | 19 Dec, 2023 | US11844804 |
| Patent eGrant Notification | 19 Dec, 2023 | US11844804 |
| Recordation of Patent eGrant | 19 Dec, 2023 | US11844804 |
| Patent Issue Date Used in PTA Calculation | 19 Dec, 2023 | US11844804 |
| Mail Patent eGrant Notification | 19 Dec, 2023 | US11844804 |
| Email Notification | 30 Nov, 2023 | US11844804 |
| Issue Notification Mailed | 29 Nov, 2023 | US11844804 |
FDA has granted several exclusivities to Xyosted (autoinjector). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xyosted (autoinjector), regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xyosted (autoinjector).
Exclusivity Information
Xyosted (autoinjector) holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Xyosted (autoinjector)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 28, 2021 |
Several oppositions have been filed on Xyosted (autoinjector)'s European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xyosted (autoinjector)'s generic, the next section provides detailed information on ongoing and past EP oppositions related to Xyosted (autoinjector) patents.
Xyosted (autoinjector)'s oppositions filed in EPO
Xyosted (autoinjector) has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 07, 2019, by Bandpay & Greuter. This opposition was filed on patent number EP06719329A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19150366A | Sep, 2022 | Bandpay & Greuter | Granted and Under Opposition |
| EP06719329A | Oct, 2019 | Bandpay & Greuter | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Xyosted (autoinjector) is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xyosted (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.
Xyosted (autoinjector)'s family patents
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Generic Launch
Generic Release Date:
Xyosted (autoinjector)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 30, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xyosted (autoinjector) Generics:
Testosterone Enanthate is the generic name for the brand Xyosted (autoinjector). 6 different companies have already filed for the generic of Xyosted (autoinjector), with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xyosted (autoinjector)'s generic
About Xyosted (autoinjector)
Xyosted (Autoinjector) is a drug owned by Antares Pharma Inc. It is used for testosterone replacement therapy in individuals with low testosterone levels. Xyosted (Autoinjector) uses Testosterone Enanthate as an active ingredient. Xyosted (Autoinjector) was launched by Antares Pharma Inc in 2018.
Can you believe Xyosted (autoinjector) received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Xyosted (autoinjector) was approved by FDA for market use on 28 September, 2018.
Active Ingredient:
Xyosted (autoinjector) uses Testosterone Enanthate as the active ingredient. Check out other Drugs and Companies using Testosterone Enanthate ingredient
Treatment:
Xyosted (autoinjector) is used for testosterone replacement therapy in individuals with low testosterone levels.
Dosage:
Xyosted (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/0.5ML (50MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 75MG/0.5ML (75MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 100MG/0.5ML (100MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |