Heparin sodium
As of the edition of 20 October 2026, Heparin sodium is an oligosaccharide: marketed, first approved in 1949 (CH); acts on SERPINC1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1984
- Kind
- Oligosaccharide
- Brand name
- Lipo-Hepin
- First approved
- 14 June 1949 (CH)
- Approvals on record
- 185 in 4 regions
- Holder of the most recent approval
- B. Braun Medical; 25 holders in all
- Registered trials
- 22, 2 stopped early
- Disease areas
- Heart and blood vessels; Infections; Nervous system; Lungs and airways; Urinary and reproductive; Blood and lymph
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
CorMedix Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2042; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Heparin sodium.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SERPINC1 | Antithrombin-III | P01008 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 12 | 5 | 0 | 2 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Later holder | 1982 to now |
| B. Braun Medical | Later holder | 1984 to now |
| LEO Pharma | Applicant | 1984 to now |
| Pfizer | Acquired holder and Later holder | 1994 to now |
| 3M | Acquired holder | 2003 to now |
| Chamberlin Parenteral | Acquired holder | 2003 to now |
| Pharmaceutical Specialist Assoc | Acquired holder | 2003 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| IBSA Institut Biochimique | Applicant | 2006 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Dr. Reddy's | Acquired holder | 2019 to now |
| Hikma Pharmaceuticals | Acquired holder | 2022 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Aspen | Acquired holder | 2024 to now |
| Abbott | Later holder | |
| Akorn | Later holder | |
| Astellas | Later holder | |
| Dell | Later holder | |
| Eli Lilly | Later holder | |
| Organon | Earlier holder |