Register entry
Antares Pharma, Inc
- Registered sites
- 1
- Drug products
- 11
- Live patents
- 51
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
LabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Antares Pharma, Inc. | Hopkins, MNUnited States | Labelling, Finished drug manufacture, Packaging | 2182861 |
Exclusivity
Patents
51Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Oct 2026 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Mar 2030 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Jul 2031 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Aug 2031 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Jun 2033 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Feb 2034 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Oct 2034 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Feb 2035 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Feb 2035 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Aug 2035 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Oct 2035 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Nov 2035 |
| XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | Sept 2036 |
Catalogue
Marketed products
11Showing 11 of 11.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| HYLENEX Recombinant | Hyaluronidase | INJECTION, SOLUTION | BLA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| Otrexup | methotrexate | INJECTION, SOLUTION | NDA |
| XYOSTED | testosterone enanthate | INJECTION | NDA |
| XYOSTED | testosterone enanthate | INJECTION | NDA |
| XYOSTED | testosterone enanthate | INJECTION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.