DAWNZERA (AUTOINJECTOR) — FDA application NDA219407
Listed sponsor: IONIS PHARMS INC · IONS company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | DAWNZERA (AUTOINJECTOR) | DONIDALORSEN SODIUM | SOLUTION | SUBCUTANEOUS | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 9315811 | 001 | listed patent expiry date: 2032-10-21 | U-3010 |
| Patent 9127276 | 001 | listed patent expiry date: 2034-05-01 | drug substance |
| Patent 9181549 | 001 | listed patent expiry date: 2034-05-01 | drug substance |
| Patent 9670492 | 001 | listed patent expiry date: 2034-08-28 | drug substance |
| Patent 10294477 | 001 | listed patent expiry date: 2035-05-01 | drug substance, drug product, U-3010 |
| Exclusivity ODE-550 | 001 | listed exclusivity date: 2032-08-21 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- DONIDALORSEN SODIUM · UNII Y30VEG5PH1 · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.