Data / Drug companies / Swedish Orphan Biovitrum AB (publ)
Swedish Orphan Biovitrum AB (publ): 14 products in the FDA NDC directory, labeler code 66658
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Swedish Orphan Biovitrum AB (publ) (labeler code 66658) lists 14 products in the FDA National Drug Code Directory, covering 4 finished drugs by generic name. By type: 14 prescription drugs. Its main marketing category is biologics (BLA). The newest product started marketing on August 4, 2023.
The request: Watch Swedish Orphan Biovitrum AB (publ) (FDA labeler code 66658): each new product listing and each discontinued product. $10 of work on sign-up, no card.
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- Labeler code
- 66658
- Products in commercial distribution
- 14
- Packages
- 15
- Finished drugs by generic name
- 4
- Prescription products
- 14
- Over the counter products
- 0
- Flagged as original packager
- 14 of 14 products that carry the flag
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- December 15, 2009
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Biologics (BLA) | 9 | 64.3% |
| New drug applications (NDA) | 5 | 35.7% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 14 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Emapalumab-lzsg | 7 | 1 |
| Nitisinone | 5 | 6 |
| Anakinra | 1 | 1 |
| Palifermin | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 7 | 50% |
| Capsule | 4 | 28.6% |
| Suspension | 1 | 7.1% |
| Injection, solution | 1 | 7.1% |
| Injection, powder, lyophilized, for solution | 1 | 7.1% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Interferon gamma Blocker | 7 |
| 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor | 5 |
| Interleukin-1 Receptor Antagonist | 1 |
| Mucocutaneous Epithelial Cell Growth Factor | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Kepivance | 66658-113 | Injection, powder, lyophilized, for solution | Biologics (BLA) | August 4, 2023 |
| Gamifant | 66658-525 | Injection | Biologics (BLA) | June 7, 2023 |
| Gamifant | 66658-524 | Injection | Biologics (BLA) | June 7, 2023 |
| Gamifant | 66658-523 | Injection | Biologics (BLA) | June 7, 2023 |
| Gamifant | 66658-522 | Injection | Biologics (BLA) | June 7, 2023 |
| Gamifant | 66658-510 | Injection | Biologics (BLA) | June 26, 2020 |
| Gamifant | 66658-505 | Injection | Biologics (BLA) | May 17, 2019 |
| Gamifant | 66658-501 | Injection | Biologics (BLA) | May 17, 2019 |
| Orfadin | 66658-120 | Capsule | New drug applications (NDA) | July 1, 2016 |
| Orfadin | 66658-110 | Capsule | New drug applications (NDA) | July 1, 2016 |
| Orfadin | 66658-105 | Capsule | New drug applications (NDA) | July 1, 2016 |
| Orfadin | 66658-102 | Capsule | New drug applications (NDA) | July 1, 2016 |
| Orfadin | 66658-204 | Suspension | New drug applications (NDA) | June 1, 2016 |
| Kineret | 66658-234 | Injection, solution | Biologics (BLA) | December 15, 2009 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.