Register entry
- Registered sites
- 1
- Active NDC listings
- 5
- Labeller names
- 2
- Live patents
- 16
- Exclusivities
- 3
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Ionis Pharmaceuticals Inc. | 2282 Faraday Ave., Carlsbad, California (CA) 92008, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3000215659011829916 |
Catalogue
Drug listings by form and route
55 active NDC listings: 4 human prescription drug, 1 bulk ingredient. By marketing category: NDA 4, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 3 |
| kit | 1 |
| powder | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 3 |
| Labeller name on the listing | NDCs |
|---|---|
| ionis pharmaceuticals inc. | 3 |
| ionis pharmaceuticals, inc. | 2 |
Exclusivity
Patents and exclusivities
16| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9157082 | TRYNGOLZA (AUTOINJECTOR)olezarsen sodium | use | Apr 2032 |
| 9315811 | DAWNZERA (AUTOINJECTOR)donidalorsen sodium | use | Oct 2032 |
| 9593333 | TRYNGOLZA (AUTOINJECTOR)olezarsen sodium | use | Feb 2034 |
| 12509684 | TRYNGOLZA (AUTOINJECTOR)olezarsen sodium | use | May 2034 |
| 9127276 | DAWNZERA (AUTOINJECTOR), TRYNGOLZA (AUTOINJECTOR)donidalorsen sodium; olezarsen sodium | substance | May 2034 |
| 9163239 | TRYNGOLZA (AUTOINJECTOR)olezarsen sodium | substance | May 2034 |
| 9181549 | DAWNZERA (AUTOINJECTOR), TRYNGOLZA (AUTOINJECTOR)donidalorsen sodium; olezarsen sodium | substance | May 2034 |
| 9670492 | DAWNZERA (AUTOINJECTOR)donidalorsen sodium | substance | Aug 2034 |
| 10294477 | DAWNZERA (AUTOINJECTOR)donidalorsen sodium | substance, product | May 2035 |
| Product | Exclusivity | Until |
|---|---|---|
| DAWNZERA (AUTOINJECTOR)DONIDALORSEN SODIUM | ODE-550 Orphan drug | Aug 2032 |
| TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUM | NS New strength | Jun 2029 |
| TRYNGOLZA (AUTOINJECTOR)OLEZARSEN SODIUM | ODE-515 Orphan drug | Dec 2031 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DAWNZERA | donidalorsen | injection, solution, subcutaneous | 71860-103NDA |
| TRYNGOLZA | olezarsen sodium | injection, solution, subcutaneous | 71860-101NDA |
| TRYNGOLZA | olezarsen sodium | injection, solution, subcutaneous | 71860-102NDA |
| ZANVASTRO | zilganersen | kit | 71860-304NDA |
| - | nusinersen | powder | 71860-396BULK INGREDIENT |
Neighbours
Registered in the same town
3- Sigma-Aldrich CorporationCarlsbad, CA · 2 sites
- Novartis Pharmaceuticals CorporationCarlsbad, CA
- Carlsbad Technology, Inc.Carlsbad, CA
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Enquiry
Common questions
- Is Ionis Pharmaceuticals Inc. FDA approved?
- Ionis Pharmaceuticals 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 Ionis Pharmaceuticals Inc.'s drugs manufactured?
- The FDA register lists Carlsbad, CA. Registered operations: analytical testing, active ingredient (API) manufacture.
- What drugs does Ionis Pharmaceuticals Inc. make?
- 5 products are listed under Ionis Pharmaceuticals Inc. in the openFDA NDC Directory, most often as injection, solution; kit; powder. 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.