Register entry
NextWave Pharmaceuticals, Inc
- Registered sites
- 0
- Drug products
- 13
- Live patents
- 37
- 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
37Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | Mar 2027 |
| QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | Feb 2031 |
| QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | Aug 2033 |
| QUILLIVANT XR | METHYLPHENIDATE HYDROCHLORIDE | Mar 2029 |
| QUILLIVANT XR | METHYLPHENIDATE HYDROCHLORIDE | Feb 2031 |
Catalogue
Marketed products
13Showing 13 of 13.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DYANAVEL XR | amphetamine | TABLET, EXTENDED RELEASE | NDA |
| DYANAVEL XR | amphetamine | TABLET, EXTENDED RELEASE | NDA |
| DYANAVEL XR | amphetamine | TABLET, EXTENDED RELEASE | NDA |
| DYANAVEL XR | amphetamine | TABLET, EXTENDED RELEASE | NDA |
| Dyanavel XR | amphetamine | SUSPENSION, EXTENDED RELEASE | NDA |
| ONYDA XR | Clonidine hydrochloride | SUSPENSION, EXTENDED RELEASE | NDA |
| QuilliChew ER | methylphenidate hydrochloride | TABLET, CHEWABLE, EXTENDED RELEASE | NDA |
| QuilliChew ER | methylphenidate hydrochloride | TABLET, CHEWABLE, EXTENDED RELEASE | NDA |
| QuilliChew ER | methylphenidate hydrochloride | TABLET, CHEWABLE, EXTENDED RELEASE | NDA |
| Quillivant XR | methylphenidate hydrochloride | SUSPENSION, EXTENDED RELEASE | NDA |
| Quillivant XR | methylphenidate hydrochloride | SUSPENSION, EXTENDED RELEASE | NDA |
| Quillivant XR | methylphenidate hydrochloride | SUSPENSION, EXTENDED RELEASE | NDA |
| Quillivant XR | methylphenidate hydrochloride | SUSPENSION, 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.