Register entry
- Registered sites
- 1
- Active NDC listings
- 11
- Live patents
- 51
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Antares Pharma, Inc.Registrant: Antares Pharma, Inc | 12500 Whitewater Dr, Hopkins, Minnesota (MN) 55343, United States (USA) | Labelling, Finished drug manufacture, Packaging | 2182861133621198 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 human prescription drug. By marketing category: NDA 10, BLA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 8 |
| injection | 3 |
| Route | NDCs |
|---|---|
| subcutaneous | 11 |
| Labeller name on the listing | NDCs |
|---|---|
| antares pharma, inc. | 11 |
Exclusivity
Patents and exclusivities
51| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8021335 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Oct 2026 |
| 11497753 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Mar 2030 |
| 10279131 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Jul 2031 |
| 10357609 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Aug 2031 |
| 10905827 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Aug 2031 |
| 11446440 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Aug 2031 |
| 10821072 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Jun 2033 |
| 11844804 | XYOSTED (AUTOINJECTOR)testosterone enanthate | use | Jun 2033 |
| 10881798 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Feb 2034 |
| 11160751 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Oct 2034 |
| 10238662 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Feb 2035 |
| 10912782 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Feb 2035 |
| 11813435 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Feb 2035 |
| 12629483 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Aug 2035 |
| 11191908 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Oct 2035 |
| 9744302 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Nov 2035 |
| 9950125 | XYOSTED (AUTOINJECTOR)testosterone enanthate | product | Sept 2036 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| HYLENEX Recombinant | Hyaluronidase | injection, solution, subcutaneous | 18657-117BLA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-010NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-012NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-015NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-017NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-020NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-022NDA |
| Otrexup | methotrexate | injection, solution, subcutaneous | 54436-025NDA |
| XYOSTED | testosterone enanthate | injection, subcutaneous | 54436-200NDA |
| XYOSTED | testosterone enanthate | injection, subcutaneous | 54436-250NDA |
| XYOSTED | testosterone enanthate | injection, subcutaneous | 54436-275NDA |
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Enquiry
Common questions
- Is Antares Pharma, Inc FDA approved?
- Antares Pharma, Inc holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Antares Pharma, Inc's drugs manufactured?
- The FDA register lists Hopkins, MN. Registered operations: labelling, finished drug manufacture, packaging.
- What drugs does Antares Pharma, Inc make?
- 11 products are listed under Antares Pharma, Inc in the openFDA NDC Directory, most often as injection, solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.