Heparin
As of the edition of 20 October 2026, Heparin is an oligosaccharide: marketed, first approved in 1949 (CH); acts on SERPINC1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Oligosaccharide
- Brand name
- Lipo-Hepin
- First approved
- 14 June 1949 (CH)
- Approvals on record
- 194 in 6 regions
- Holder of the most recent approval
- Abbott; 32 holders in all
- Registered trials
- 159, 24 stopped early
- Disease areas
- Heart and blood vessels; Infections; Lungs and airways; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Heparin.
See the 5 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 | 45 | 22 | 9 | 6 |
| Phase 1 | 16 | 9 | 2 | 0 |
| Phase 2 | 22 | 8 | 3 | 6 |
| Phase 3 | 36 | 21 | 3 | 7 |
| Phase 4 | 40 | 22 | 3 | 5 |
| All trials | 159 |
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 |
| Eurofarma Laboratorios | Applicant | 2001 to now |
| Eli Lilly | Later holder and Lead sponsor of trials | 2002 to now |
| 3M | Acquired holder | 2003 to now |
| Chamberlin Parenteral | Acquired holder | 2003 to now |
| Pharmaceutical Specialist Assoc | Acquired holder | 2003 to now |
| Sanofi | Later holder and Lead sponsor of trials | 2003 to now |
| Cristália Produtos Químicos Farmacêuticos Ltda | Later holder | 2004 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| IBSA Institut Biochimique | Applicant | 2006 to now |
| Blau Farmaceutica | Later holder and Lead sponsor of trials | 2008 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 | |
| Organon | Earlier holder |