Register entry
Aytu Therapeutics, LLC
- Registered sites
- 0
- Drug products
- 11
- Live patents
- 3
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
3Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| KARBINAL ER | CARBINOXAMINE MALEATE | Jun 2027 |
| KARBINAL ER | CARBINOXAMINE MALEATE | Mar 2029 |
| ZOLPIMIST | ZOLPIDEM TARTRATE | Aug 2032 |
Catalogue
Marketed products
11Showing 11 of 11.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| EXXUA | gepirone | TABLET, EXTENDED RELEASE | NDA |
| EXXUA | gepirone | TABLET, EXTENDED RELEASE | NDA |
| EXXUA | gepirone | TABLET, EXTENDED RELEASE | NDA |
| EXXUA | gepirone | TABLET, EXTENDED RELEASE | NDA |
| Karbinal ER | Carbinoxamine Maleate | SUSPENSION, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | 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.