Register entry
Ionis Pharmaceuticals Inc.
- Registered sites
- 1
- Drug products
- 4
- Live patents
- 16
- 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.
Analytical testingActive ingredient (API) manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Ionis Pharmaceuticals Inc. | Carlsbad, CAUnited States | Analytical testing, Active ingredient (API) manufacture | 3000215659 |
Exclusivity
Patents
16Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DAWNZERA (AUTOINJECTOR) | DONIDALORSEN SODIUM | Oct 2032 |
| DAWNZERA (AUTOINJECTOR) | DONIDALORSEN SODIUM | May 2034 |
| DAWNZERA (AUTOINJECTOR) | DONIDALORSEN SODIUM | Aug 2034 |
| DAWNZERA (AUTOINJECTOR) | DONIDALORSEN SODIUM | May 2035 |
| TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | Apr 2032 |
| TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | Feb 2034 |
| TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | May 2034 |
Catalogue
Marketed products
4Showing 4 of 4.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DAWNZERA | donidalorsen | INJECTION, SOLUTION | NDA |
| TRYNGOLZA | olezarsen sodium | INJECTION, SOLUTION | NDA |
| TRYNGOLZA | olezarsen sodium | INJECTION, SOLUTION | NDA |
| - | nusinersen | POWDER | BULK INGREDIENT |
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.